Clinical Research Registry

No Registry Status Registry
  Awal   Comparative Study of Efficacy and Safety Lynestrenol versus Exluton® in Women of Childbearing Age 
Interventions: This is a prospective, randomized, open label, comparative, parallel study to evaluate efficacy and safety of 0.5 mg lynestrenol during 12 months of drug administration. The randomization code is tabulated for all subjects according to block randomization with a block size of 4 (Dixon & Massey, 1969, p 447). The study will be conducted in PT Equilab International as the study center in collaboration with some midwife clinics in Jakarta and surrounding areas. The data of pregnancy occurrence will be evaluated by urine HCG test every 2 months at until 12 months of evaluation period. The data of adverse events occurred during the study will be collected based on subject’s diary, anamnesis, and medical examination. Subjects are not allowed to use other contraception except the investigational product (0.5 mg Lynestrenol that dispensed from the study site) 
INA-8EAHA56  Awal   Studi Efektivitas Monoplant® dibandingkan dengan Indoplant® 
Interventions: Studi ini merupakan uji klinik fase III, ‘terbuka’ (‘open label’ Randomized Clinical Trial), dilakukan randomisasi serta multisenter, dengan membandingkan dua macam susuk KB yaitu Monoplant® dan Indoplant® yang dilakukan pada wanita sehat Indonesia. Blok random alokasi persepuluhan dan ditetapkan secara random dibagi 5 Monoplant dan 5 Indoplant. Total sampel yang akan diamati dalam studi ini: 450 subjek wanita pemakai Monoplant® dan 450 subjek wanita pemakai Indoplant® di 5 (lima) senter di Indonesia, yaitu Jakarta, Semarang, Surabaya, Palembang dan Makassar. Tiap senter akan merekrut lebih kurang 180 subjek (90 akseptor Monoplant dan 90 akseptor Indoplant), untuk kedua jenis susuk KB ini tergantung dari kemampuan dan kesanggupan senter merekrut sampelnya. Pengamatan terhadap subjek dilakukan selama 3 tahun. Pengambilan darah untuk pemeriksaan kadar LNG dilakukan subsampel (33 subjek) untuk masing-masing susuk KB Monoplant dan Indoplant, khususnya pada subjek di senter Jakarta. Pemeriksaan kadar LNG dalam darah dilakukan di PT. Equilab Internasional. 
INA-P1WG34P  Awal   INA-PROACTIVE 
Interventions: No Intervention 
INA-LML8DP8  Awal   Profil Keamanan Vaksin Td (Bio Farma) pada Ibu Hamil di Indonesia 
Interventions:
INA-2FRR4L5  Awal   Safety and Immunogenicity of Rotavirus (Bio Farma) Vaccine in Adults, Children and Neonates (Phase I) 
Interventions: Adult&Children: One dose of Rotavirus Vaccine Neonates: Three doses of Rotavirus Vaccine 
INA-BCER292  Awal   Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children 
Interventions: 1 dose Measles Rubella (MR) vaccine 
INA-3PTS6EX  Awal   Protectivity and Safety of Quadrivalent Influenza HA Vaccine in Indonesian Population 
Interventions: 9-40 years old: 1 dose of Quadrivalent Influenza Vaccine 6 months - 8 years old: 2 dose of Quadrivalent Influenza Vaccine 
INA-35ST1PS  Awal   Safety and immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Indonesian adults, adolescents, children and infants (Phase II) 
Interventions: 1 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine 
INA-AB1DBOS  Awal   Safety and Immunogenicity of Vi-DT Typhoid Conjugate Vaccine (Bio Farma) in Adults and Children (Phase I) 
Interventions: 2 dose of 0.5 ml of Vi-DT Conjugated typhoid vaccine 
INA-C273S0L  Awal   Immunogenicity and Safety Profile of Primary Dose of bivalent OPV (bOPV Bio Farma) Given Simultaneously with Pentabio® and Inactivated poliovirus vaccine (IPV) at the 4th Visit in Indonesian Infants 
Interventions: bOPV one dose corresponds to 2 drops (0.1ml). The vaccine shall be given orally. The subject received bOPV, Pentabio and IPV according to the study schedule. 
INA-H9W8EPN  Awal   TT063 STUDY 
Interventions: The following 2 groups are examined. The subjects are randomly allocated to these groups at the ratio of 1:1. SFPP group: One patch of SFPP is applied to the assessed knee once daily. Diclofenac (DC) group: Two gram of diclofenac gel per application is applied to the assessed knee 4 times daily. Pre-treatment Drugs: Patients take celecoxib 200 mg per day prescribed by investigator from screening visit (1st visit) to washout visit (2nd visit) as the pre-treatment for knee OA. Rescue Drugs: Use of paracetamol 1,000 mg once daily as the rescue drugs for knee pain is permitted from washout visit (2nd visit) to the end of final tests and observation only when the subjects cannot tolerate their knee pain (ex. they cannot rise up from chair). [Exception] Rescue drugs cannot be used within two days before the scheduled site visits. 
INA-7GNRTO6  Awal   Tuberculosis Research of INA-RESPOND On Drug Resistance 
Interventions: Tidak ada Intervensi; Observational 
INA-PLE3XOP  Awal   Implementing a Combination of Clinical Parameters (Rapid Diagnostic Tests (RDTs), Biomarkers, and Standard of Care Procedures (SoCs) for the Etiology Diagnoses of Pneumonia in Pediatric Patients to Improve Clinical Management in Indonesia. 
Interventions: Not Applicable, this is observational study 
INA-ODE8ELW  Awal   S-Collate 
Interventions: All clinical information and laboratory parameters documented for this observational study prior to start of PEG IFN treatment and during this study were routinely assessed as SOC and not for the purpose of this study. Patient’s medical history, demographics, and disease characteristics were extracted from the medical record, as well as the CHB treatment observations (dose and exposure), concomitant medication and AEs. To evaluate serological and virological treatment response the respective tests were done as routine procedures, test kits and frequency of measuring depending on SOC in the respective clinic/practice. Patients were observed for the duration of PEG IFN treatment and for up to 3 years afterwards. 
INA-XL122KL  Awal   FastAct II 
Interventions: In this phase 3 trial, patients with untreated stage IIIB/IV non-small-cell lung cancer were randomly assigned in a 1:1 ratio by use of an interactive internet response system with minimisation algorithm (stratified by disease stage, tumour histology, smoking status, and chemotherapy regimen) to receive six cycles of gemcitabine (1250 mg/m(2) on days 1 and 8, intravenously) plus platinum (carboplatin 5 × area under the curve or cisplatin 75 mg/m(2) on day 1, intravenously) with intercalated erlotinib (150 mg/day on days 15-28, orally; chemotherapy plus erlotinib) or placebo orally (chemotherapy plus placebo) every 4 weeks. With the exception of an independent group responsible for monitoring data and safety monitoring board, everyone outside the interactive internet response system company was masked to treatment allocation. Patients continued to receive erlotinib or placebo until progression or unacceptable toxicity or death, and all patients in the placebo group were offered second-line erlotinib at the time of progression. The primary endpoint was PFS in the intention-to-treat population. 
INA-4Q9Y8KM  Awal   ActUp 
Interventions: This is a 6-month non-interventional, observational, post-marketing, multi-center and local study in RA patients, who are currently being treated with tocilizumab. This study is observational therefore no additional visits will be required, no study-specific medication will be administered and no other interventional procedures additional to those comprising routine clinical practice will be performed. The co-morbidities of patients meeting all selection criteria will be reviewed and patients will be followed-up over a 6-month observation period. Since patients have initiated treatment prior to study start-up, data collection is partially retrospective. Data collection will include the following sources: - Patients’ co-morbidities. - Data recorded by the principal investigator and collaborators during the routine visits of the patient. Since the study is observational, the visits are those pre-scheduled as part of usual clinical practice. These include: - One enrolment visit (this visit may occur up to 8 weeks after the first tocilizumab treatment, and in this case data collection will be retrospectively collected up to the first tocilizumab treatment). - Usual follow-up visits according to the center’s practice, which will take place during the study observation period up to 6 months after tocilizumab treatment initiation. - One final visit, corresponding to that performed nearest to 6 months after tocilizumab treatment initiation. Additional tests for the recruited patients are not foreseen, since this is an observational study. The doses and duration of treatment will be stipulated by the Investigator, according to local guidelines and/or routine clinical practice. No study-specific drug will be administered. The dose and duration of treatment before, during, and after the study will be based upon the Investigator’s judgment and in accordance with the label and local regulations. Tocilizumab administration may occur as per routine practice and following the local label. Treatment-related information (including efficacy and safety information, where available) may be collected at the same time-points as tocilizimab administration, but will be at the discretion of the investigator in line with local routine practice. The study population will include patients with moderate to severe RA, according to ACR criteria [13] and DAS28 joint scores [43], in whom the treating physician has made the decision to commence tocilizumab treatment (in accordance with the local label). This can include patients who have received tocilizumab treatment within 8 weeks prior to the enrollment visit. Furthermore, patients must have given their informed consent and must not meet any of the exclusion criteria 
INA-P0Q2OY0  Awal   SafeHer 
Interventions: Eligible patients with HER2-positive EBC will be allocated to one of the two following cohorts at the investigator’s discretion: • Cohort A (approximately 1800 patients): trastuzumab SC 600 mg via assisted administration into the thigh over a period of approximately 5 minutes using handheld syringes with hypodermic needles • Cohort B (approximately 700 patients): trastuzumab SC 600 mg, first assisted, then self-administered into the thigh over a period of approximately 5 minutes using the SID. For enrollment into Cohort B, patients need to be willing to self-administer the study drug from the SID based on personal instructions/training provided by an HCP during the first assisted administration in addition to a quick reference guide and an instructional animation describing the injection device handling and use, including how to respond if the SID loses sufficient contact with the body. 
INA-NK1QGRZ  Awal   A RANDOMIZED, OPEN-LABEL, MULTI-CENTRE STUDY TO EVALUATE PATIENT PREFERENCE WITH SUBCUTANEOUS ADMINISTRATION OF RITUXIMAB VERSUS INTRAVENOUS RITUXIMAB IN PREVIOUSLY UNTREATED PATIENTS WITH CD20+ DIFFUSE LARGE B-CELL LYMPHOMA OR CD20+ FOLLICULAR NON-HODGKIN’S LYMPHOMA GRADES 1, 2 OR 3A 
Interventions: This will be an open-label, randomized study and therefore treatment allocation will not be concealed. Eligible patients will be randomly allocated to Treatment Arm A (rituximab SC → rituximab IV) or Arm B (rituximab IV → rituximab SC) with a 1:1 ratio before dosing on Day 1 of Cycle 1. Randomization will occur using a centralized IxRS. Patients will be stratified according to age ( 
INA-A7OB6TW  Awal   Applying Wolbachia to Eliminate Dengue (AWED) Trial 
Interventions: Intervention arm: Deployment of Wolbachia-infected Aedes aegypty mosquitoes, in addition to standard practice dengue control activities Comparison arm: No intervention, Standard practice dengue control activities 
INA-GC3B3QY  Awal   NA 
Interventions: Tahap pertama: dilakukan pengambilan data ibu HIV dan bayinya. Tahap kedua: dilakukan pemeriksaan anti HIV sebelum dan saat persalinan dan bila anti HIV positiff, dilanjutkan pemeriksaan jumlah CD4 ibu. Pada saat bayi yang baru lahir dari ibu dengan HIV positif berusia 48 jam diperiksa PCR-DNA untuk menentukan satus infeksi bayi dan status terjadinya transmisi intra uterin. Juga dicatat apakah ibu sudah mendapat terapi ARV sebelum dan saat hamil. Semua bayi yang lahir dengan status HIV ibu positif tidak diberikan ASI. Bayi kemudian mendapatkan profilaksis ARV berupa zidovudin (dan nevirapin bila ibu belum mendapat ARV selama hamil) sesuai rekomendasi WHO selama 6 minggu. Setelah 6 minggu pemberian profilaksis ARV, bayi diperiksa PCR RNA. Semuabayi dengan hasil PCR-DNA dan atau PCR-RNA positif, langsung diberikan terapi ARV. Konfirmasi ulang dilakukan pemeriksaan PCR RNA pada usia bayi 12 minggu untuk menentukan status akhir infeksi pada bayi. 
INA-4E24W1E  Awal   NA 
Interventions: Pasien dibagi dalam 2 kelompok A dan B (setelah randomisasi) masing-masing mendapatkan obat sesuai pengelompokaan subyek selama 10 hari. Vitamin E menggunakan Santa E chewable caplet suatu DL-alpha-tocopheol dengan dosis 40 UI/hari (setara dengan Santa E 40mg) satu kali sehari yang dibuat dalam bentuk puyer. Placebo menggunakan sakarin dengan dosis dan dibuat salam bentuk puyer yang serupa dengan Santa E. 
INA-F7X6NA4  Awal   NA 
Interventions: Injeksi stem cells 
INA-SSS4TD0  Awal   Mesenchymal Stem cells ,spinal cord injury 
Interventions: Penyuntikan steam cells 
INA-OO80ADB  Awal   Global Safety T-DM1 Trial 
Interventions: - Test product: Trastuzumab emtansine (T-DM1) - Target population: This study will enroll patients with human epidermal growth factor receptor 2 (HER2)positive, unresectable, locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have previously received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. - Study design: Patients will be divided into two cohorts: Cohort 1 (approximately 2000 patients) and Cohort 2 (approximately 220 patients only of Asian race). Patients in each cohort will be administered trastuzumab emtansine intravenously every 3 weeks at a dose of 3.6 mg/kg until one of the following conditions, whichever occurs first: unacceptable toxicity, withdrawal of consent, disease progression, death, or up to a maximum of 2 years after the last patient has been enrolled into Cohort 1 (for patients in Cohort 1) or Cohort 2 (for patients in Cohort 2). 
INA-BXNGOQD  Awal   Global Safety T-DM1 Trial 
Interventions: - Test product: Trastuzumab emtansine (T-DM1) - Target population: This study will enroll patients with human epidermal growth factor receptor 2 (HER2)positive, unresectable, locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) who have previously received prior anti-HER2 and chemotherapy treatment and have progressed on or after the most recent treatment for LABC or mBC, or within 6 months of completing adjuvant therapy. - Study design: Patients will be divided into two cohorts: Cohort 1 (2000 patients) and Cohort 2 (220 patients only of Asian race). Patients in each cohort will receive trastuzumab emtansine until one of the following conditions, whichever occurs first: unacceptable toxicity, withdrawal of consent, disease progression, death, or up to a maximum of 2 years after the last patient has been enrolled into Cohort 1 (for patients in Cohort 1) or Cohort 2 (for patients in Cohort 2) 
INA-KPA0DYA  Awal   NENOIN Study 
Interventions: NA NENOIN STUDY is designed to be a Phase IV/observational study and non-interventional. This observational study will not interfere with treatment prescription by Investigators. Accordingly, the Investigator will decide in advance the best therapeutic strategy for each subject according to current practice, regardless of the potential participation of the subject in the study. Subsequently, if the prescribed treatment is to be in line with the study protocol inclusion criteria, the Investigator will consider the possibility of including the subject in the study if subject signs informed consent form. 
INA-7GNRTO6  Awal   INA102 – TUBERCULOSIS RESEARCH OF INA-RESPOND ON DRUG RESISTANCE (TRIPOD) 
Interventions: N/A 
INA-9WS4RE6  Awal   INA101: The Etiology of Acute Febrile Illness Requiring Hospitalization (AFIRE) 
Interventions: N/A 
INA-RX5D5QD  Awal   Uji Klinis Probiotik Lactobacillus plantarum pada Pasien Dermatitis Atopik Anak di RSUD Dr. Soetomo Surabaya 
Interventions: • Metode Intervensi / Eksperimental Metode uji klinis terkontrol acak, tersamar ganda, tanpa pemilihan pasangan serasi, desain paralel • Bahan Uji ➢ Bahan uji pada kelompok perlakuan yaitu Lactobacillus plantarum 1,120 gram (10 pangkat 10 Colony Factor Unit) ➢ Bahan uji pada kelompok kontrol yaitu plasebo berupa campuran susu skim dan avicel (selulose) • Kondisi Kesehatan Subyek Pasien dermatitis atopik anak usia 0-14 tahun dengan keadaan umum baik dan memenuhi kriteria inklusi 
INA-R5PG64K  Awal   Uji Klinis Gel Produk Metabolisme Sel Punca Membran Amnion pada Penyembuhan Luka Kronis Telapak Kaki Pasien Kusta 
Interventions: Metode Intervensi/Eksperimental : Uji klinis terkontrol, pemilihan pasangan serasi,desain paralel Bahan Uji: - Pada kelompok perlakuan : produk metabolit Amniotic Membrane Stem Cell (AMSC) yang diperoleh dari Laboratorium Stem Cell, Institute Tropical Disease, Universitas Airlangga, yang dibuat gel terlebih dahulu supaya dapat diaplikasikan pada luka. - Pada kelompok kontrol : framycetin gauze dressing Kondisi Kesehatan Subyek Penelitian : Pasien Morbus Hansen dengan keadaan umum baik, dengan ulkus plantar kronis sederhana yang memenuhi kriteria inklusi dan eksklusi