Clinical trials: in Indonesia
Systemic Lupus Erythematosus
Belimumab Assessment of Safety in SLE
The purpose of this study is to further enhance the existing knowledge regarding the side effects of belimumab when given with other lupus medicines to adults with active systemic lupus erythematosus (SLE).
- Trial name
- BASE (NCT01705977)
- Testing
- Belimumab 10 mg/kg plus standard therapy, Standard therapy
- Where
- 250 sites in United States, Argentina and 31 more
- Volunteers
- 4,019 people
- Sponsor
- GlaxoSmithKline
Lung Tuberculosis, MDR TB
Tuberculosis Research of INA-RESPOND On Drug Resistance
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray…
- Trial name
- TRIPOD (NCT02758236)
- Testing
- No Intervention
- Where
- 7 sites in Indonesia
- Volunteers
- 490 people
- Sponsor
- Ina-Respond
Beta Thalassemia Major Anemia, Iron Overload
Safety and Efficacy of Early Treatment With Deferiprone in Infants and Young Children
This study is looking at the effects of giving early treatment of deferiprone to young children with beta thalassemia who have started receiving regular blood transfusions but have not yet reached the criteria for starting on…
- Trial name
- START (NCT03591575)
- Testing
- Deferiprone oral solution
- Where
- 4 sites in Egypt, Indonesia
- Volunteers
- 64 people
- Sponsor
- Chiesi Canada Corp
Pelvic Floor Disorders
Platelet Rich Plasma in Levator Ani Muscle Trauma
Levator trauma (ballooning) often occurs after vaginal delivery. Platelet rich plasma injection after delivery showed reduced hiatal area and maintain levator muscle strength.
- Trial name
- NCT03021954
- Testing
- Platelet Rich Plasma
- Where
- Indonesia
- Volunteers
- 116 people, healthy volunteers welcome
- Sponsor
- Dr Cipto Mangunkusumo General Hospital
Sudden Cardiac Arrest, Acute Myocardial Infarction
Improve SCA Bridge Study
The purpose of the Improve SCA Bridge study is to characterize the care pathway flow of post-acute myocardial infarction (MI) patients as a result of standard assessments of left ventricular ejection fraction (LVEF) in the acute…
- Trial name
- NCT03715790
- Testing
- EP referred group, Non-Referred group
- Where
- 52 sites in Bangladesh, Brunei and 14 more
- Volunteers
- 1,491 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Chronic Kidney Disease, Cardiac Disease
Low Dose Continuous Furosemide Effect on Cardiac Surgery Patients With Kidney Dysfunction
Chronic kidney disease is an independent risk factor for cardiovascular disease associated with increased mortality rate during cardiac surgery in proportion to the kidney function.
- Trial name
- NCT04919564
- Testing
- Furosemide in 0.9 % NaCl 100 Mg/100 mL (1 mg/mL), NaCl 0.9%
- Where
- Indonesia
- Volunteers
- 90 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Urinary Tract Infections
Effectiveness of Preurodynamic With Posturodynamic Levofloxacin on the Incidence of UTI
This study aims to compare the effectiveness of preoperative single dose of levofloxacin with postoperative levofloxacin for three days on the incidence of urinary tract infections (UTI) after urodynamic examination.
- Trial name
- NCT05219877
- Testing
- Pre-urodynamic Levofloxacin, Post-urodynamic Levofloxacin
- Where
- Indonesia
- Volunteers
- 134 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Coronary Artery Bypass, Cardiopulmonary Bypass
Role of Glutamine as Myocardial Protector in Elective On-Pump CABG Surgery With Low EF
Coronary artery disease has the highest mortality rate worldwide and coronary artery bypass grafting (CABG) is the most common cardiac surgery performed in patients with coronary artery disease to revascularize the heart.
- Conditions
- Coronary Artery Bypass, Cardiopulmonary Bypass, Coronary Artery Disease
- Trial name
- NCT04560309
- Testing
- L-alanyl-L-glutamine dipeptide
- Where
- Indonesia
- Volunteers
- 60 people
- Sponsor
- National Cardiovascular Center Harapan Kita Hospital Indonesia
Drug Use
Bioequivalence Study of Furosemide 40 mg Tablet in 24 Indonesian Healthy Volunteers
The purpose of this research was to investigate whether Furosemide 40 mg tablet manufactured by PT. Kimia Farma Tbk was bioequivalent to its reference drug and Lasix® 40 mg Tablet manufactured by PT. Aventis Pharma, Indonesia.
- Trial name
- NCT04982874
- Testing
- Furosemide 40 mg, Lasix® 40 mg Tablet
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT. Kimia Farma (Persero) Tbk
Acute Febrile Illness
The Etiology of Acute Febrile Illness Requiring Hospitalization
This study is an observational cohort study of hospitalized patients with fever. This study will collect demographic data, history of illness, signs and symptoms, results of laboratory tests, clinical course, treatment and…
- Trial name
- AFIRE (NCT02763462)
- Where
- 8 sites in Indonesia
- Volunteers
- 1,492 people
- Sponsor
- Ina-Respond
Drug Use
Pharmacokinetic Properties of 200 and 400 mg Acyclovir Tablet in Indonesia Healthy Subject
The objective of this present study was to asses the pharmacokinetic properties of acyclovir tablet from new product formulation (PT.
- Trial name
- NCT04988646
- Testing
- Acyclovir 200 MG, Acyclovir 400 MG, Zovirax 200 MG Tablet
- Where
- Indonesia
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- PT. Kimia Farma (Persero) Tbk
Maxillofacial Injuries, Maxillofacial Prosthesis Implantation
A Clinical Trial of Locally Made Titanium Miniplate and Screw in Maxillofacial Fractures Management
The study is a blind randomized clinical study on patients with midface maxillofacial fractures coming to Cipto Mangunkusumo Hospital.
- Conditions
- Maxillofacial Injuries, Maxillofacial Prosthesis Implantation, Fracture Fixation, Internal
- Trial name
- NCT04279925
- Testing
- ORIF (Open reduction internal fixation): locally-made miniplate and screw, ORIF: Imported miniplate and screw
- Where
- Indonesia
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- Universitas Indonesia
Breast Cancer
A Study of Trastuzumab Emtansine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment
This two-cohort, open-label, multicenter study will assess the safety, efficacy and tolerability of trastuzumab emtansine in participants with HER2-positive locally advanced breast cancer (LABC) or metastatic breast cancer (mBC)…
- Trial name
- NCT01702571
- Testing
- Trastuzumab Emtansine
- Where
- 300 sites in Argentina, Australia and 41 more
- Volunteers
- 2,185 people
- Sponsor
- Hoffmann-La Roche
Dengue, Dengue Fever
Study of a Novel Tetravalent Dengue Vaccine in Healthy Children Aged 2 to 14 Years in Asia
The aim of the trial was to assess the efficacy of the CYD dengue vaccine in preventing symptomatic, virologically-confirmed dengue (VCD) cases.
- Conditions
- Dengue, Dengue Fever, Dengue Hemorrhagic Fever
- Trial name
- NCT01373281
- Testing
- Live, attenuated, dengue serotype 1, 2, 3, 4 virus
- Where
- 12 sites in Indonesia, Malaysia and 3 more
- Volunteers
- 10,275 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Drug Use
Bioequivalence Study of Cyproterone Acetate and Ethinyl Estradiol in Healthy Female Volunteers
The study was conducted to investigate whether 2 mg cyproterone acetate (CPA) and 0.035 mg ethinyl estradiol (EE) film-coated tablet (Elzsa®) manufactured by PT.
- Trial name
- NCT04964193
- Testing
- Elzsa film-coated tablet, Diane-35 Sugar-coated tablet
- Where
- Indonesia
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- PT Sydna Farma
Malaria
Pyronaridine Artesunate (3:1) in Children and Adults With Acute Plasmodium Vivax Malaria
The purpose of this study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) (180:60 mg) with that of standard chloroquine therapy in children and adults with acute…
- Trial name
- NCT00440999
- Testing
- Pyronaridine artesunate, Chloroquine
- Where
- 5 sites in Cambodia, India and 2 more
- Volunteers
- 456 people
- Sponsor
- Medicines for Malaria Venture
Plasmodium Falciparum Malaria
Phase II Dose-ranging Study of Pyronaridine/Artesunate in Adults Patients With Plasmodium Falciparum Malaria
The primary trial objective is to determine the clinically effective dose of orally administered pyronaridine/artesunate (Pyramax®, PA) with a 3:1 ratio to treat adults with acute, symptomatic, uncomplicated P.
- Trial name
- NCT01594931
- Testing
- pyronaridine/artesunate
- Where
- 6 sites in Cambodia, Indonesia and 4 more
- Volunteers
- 477 people
- Sponsor
- Medicines for Malaria Venture
Malaria
Pyronaridine Artesunate (3:1) Versus Coartem® in P Falciparum Malaria Patients
The primary objective of this phase III study is to compare the efficacy and safety of the fixed combination of pyronaridine artesunate (Pyramax®, PA) with that of Coartem® (artemether lumefantrine, AL) in children and adults…
- Trial name
- NCT00422084
- Testing
- Pyronaridine artesunate, Coartem® (artemether lumefantrine)
- Where
- 10 sites in Democratic Republic of the Congo, Ghana and 7 more
- Volunteers
- 1,272 people
- Sponsor
- Medicines for Malaria Venture
Heart Failure
ASIAN HF Registry, A Prospective Observational Study
The ASIAN HF Registry is the first prospective multinational Asian registry of patients with symptomatic HF (stage C) including both HFrEF (ejection fraction <40%) and HFpEF (ejection fraction ≥50%), with the broad purpose of…
- Trial name
- ASIANHF (NCT01633398)
- Testing
- Saliva Genetic testing
- Where
- 11 sites in China, Hong Kong and 9 more
- Volunteers
- 6,329 people
- Sponsor
- Carolyn Lam
Breast Neoplasms
A Safety and Tolerability Study of Assisted and Self-Administered Subcutaneous (SC) Herceptin (Trastuzumab) as Adjuvant Therapy in Early Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
This multicenter, two-cohort, non-randomized, open-label study will evaluate the safety and tolerability of assisted and self-administered SC Herceptin as adjuvant therapy in participants with early HER2-positive breast cancer…
- Trial name
- SafeHER (NCT01566721)
- Testing
- Herceptin
- Where
- 437 sites in Albania, Algeria and 57 more
- Volunteers
- 2,577 people
- Sponsor
- Hoffmann-La Roche