Clinical trials: in Indonesia
Poliomyelitis
A Study to Evaluate the Safety and Immunogenicity of VLP-Polio in Infants and Toddlers
This is a phase I/II randomized, double-blind, and positive-controlled study. Participants in the phase I toddler group will receive 1 dose of either high dose VLP-Polio (Dose H) or control vaccine in a ratio of 3:1.
- Trial name
- NCT06577298
- Testing
- Recombinant Trivalent Poliomyelitis Vaccine (Sf-RVN Cell) (VLP-Polio) low adjuvant dose, VLP-Polio medium dose, VLP-Polio high dose
- Where
- Indonesia
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Meningococcal Meningitis
A Clinical Trial to Evaluate the Immunogenicity and Safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in Adults Aged 18 to 55 Years
This is a multicenter, randomized, double-blinded, positive controlled study to evaluate the lot-to-lot consistency, immunogenicity and safety of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) in adults aged 18 to 55…
- Trial name
- NCT06131554
- Testing
- batch 1 of Group ACYW135 Meningococcal Conjugate Vaccine (CRM197) (MCV4), batch 2 of MCV4, batch 3 of MCV4
- Where
- Indonesia
- Volunteers
- 1,480 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Diabetes Mellitus, Type 2
A Real-world Study to Investigate Cardiovascular Risk Profile Among Newly Diagnosed Type 2 Diabetes Mellitus (T2DM) Participants
The purpose of the study is to investigate the cardiovascular disease (CVD) risk profile among participants newly diagnosed with type 2 diabetes mellitus (T2DM) in Southeast Asia (CRISTAL SEA).
- Trial name
- CRISTALSEA (NCT07532863)
- Testing
- No treatment given
- Where
- 6 sites in Indonesia, Malaysia and 2 more
- Volunteers
- 400 people
- Sponsor
- Novo Nordisk A/S
Gastric Ulcer
Phase 3 to Evaluate the Efficacy and Safety of DWP14012 in Patients With Gastric Ulcer
A Multinational, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group, Phase 3 Study to Evaluate the Efficacy and Safety of DWP14012 in Participants with Gastric Ulcer
- Trial name
- NCT07730138
- Testing
- DWP14012 40mg (Fexuprazan), Lansoprazole 30mg
- Where
- 2 sites in Indonesia, South Korea
- Volunteers
- 384 people
- Sponsor
- Daewoong Pharmaceutical Co. LTD.
Carpal Tunnel Syndrome (CTS)
Effectiveness of Amniotic Membrane Combined With Secretome as an Adjunct to Carpal Tunnel Release Surgery: Evaluation Using the Boston Carpal Tunnel Questionnaire and Electromyography
Carpal Tunnel Syndrome (CTS) is a compressive neuropathy caused by chronic compression of the median nerve within the carpal tunnel, resulting in pain, numbness, tingling, and impaired hand function.
- Trial name
- Secretome CTS (NCT07723313)
- Testing
- Secretome, amniotic membrane, Standard surgery
- Where
- Indonesia
- Volunteers
- 30 people
- Sponsor
- PT. Prodia Stem Cell Indonesia
ACL Injury, ACL Tear
Comparison of Six-Month Functional Outcomes Following Anterior Cruciate Ligament (ACL) Reconstruction Using Peroneus Longus Tendon Grafts With Adjunctive Secretome Injection Versus Without Secretome Injection
Anterior cruciate ligament (ACL) reconstruction is commonly performed to restore knee stability after ACL injury; however, graft healing remains a critical determinant of successful outcomes.
- Trial name
- Secretome ACL (NCT07723625)
- Testing
- Secretome
- Where
- Indonesia
- Volunteers
- 24 people
- Sponsor
- PT. Prodia Stem Cell Indonesia
Tuberculosis, TB Infection
A Phase I Study of Lipovaxin Tuberculosis Vaccine in Adult Healthy Populations
A Phase I, Double-Blind, Randomized, Placebo Controlled Trial to Evaluate Safety and Immunogenicity of Lipovaxin Tuberculosis Vaccine (Bio Farma) in Healthy Populations Aged 18-40 Years in Indonesia
- Trial name
- NCT07647107
- Testing
- LipovaxinS4-EAH (Middle Dose), LipovaksinS4-EAH (High Dose)
- Where
- Indonesia
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Patent Ductus Arteriosus
HeartR™ PDA Occluder Post-Market Follow-Up Study
The HeartR™ PDA Occluder Post-Market Clinical Follow-up (PMCF) Study is a multi-center, retrospective, single-arm study sponsored by Lifetech Scientific (Shenzhen) Co., Ltd., aiming to evaluate the long-term safety and…
- Trial name
- NCT07646704
- Testing
- HeartR™ PDA Occluder
- Where
- Indonesia
- Volunteers
- 140 people
- Sponsor
- Lifetech Scientific (Shenzhen) Co., Ltd.
Latent Tuberculosis Infection (LTBI)
C-TST for Diagnosis of Latent Mycobacterium Tuberculosis Infection in Indonesia
This is an operational research in household/close contacts of confirmed TB patients to evaluate the effectiveness of C-TST compared to IGRA test in identifying latent TB cases using parameters of effectiveness and safety.
- Trial name
- C-TST (NCT07587164)
- Testing
- Recombinant Mycobacterium Tuberculosis Fusion Protein Tuberculin Skin Test (C-TST)
- Where
- Indonesia
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Anemia of Chronic Kidney Disease
A Phase 3 Study of Efepoetin Alfa for Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis
An investigator-blinded, randomized, multicenter, active-controlled Phase III study for the treatment of anemia in patients with CKD on hemodialysis
- Trial name
- NCT06466785
- Testing
- Efepoetin Alfa, Darbepoetin Alfa
- Where
- 58 sites in Armenia, Bulgaria and 9 more
- Volunteers
- 429 people
- Sponsor
- Genexine, Inc.
Chronic Kidney Disease
To Determine the Accuracy of SCreening for Occult REnal Disease (SCORED) Questionnaire for CKD Risk Among Asian Patients
To determine the accuracy of SCreening for Occult REnal Disease (SCORED) questionnaire for CKD risk among Asian Patients
- Trial name
- SCREEN (NCT05866276)
- Where
- 3 sites in Indonesia, Vietnam
- Volunteers
- 1,426 people
- Sponsor
- AstraZeneca
Malaria
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring…
- Trial name
- NCT03503058
- Testing
- PfSPZ Vaccine, PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis, Normal Saline
- Where
- 2 sites in Indonesia
- Volunteers
- 345 people, healthy volunteers welcome
- Sponsor
- Sanaria Inc.
Tuberculosis
A Study to Evaluate the Safety and Immunogenicity of Ad5-105K in Adults Aged 18 to 49 Years
This is a randomized, observer-blind, positive-controlled study. There will be 2 treatment groups (Group A and B). In each treatment group, 18 participants will be randomly assigned to receive either the investigational vaccine…
- Trial name
- NCT06732583
- Testing
- Tuberculosis (TB) vaccine (Ad5-105K), Ad5-105K
- Where
- Indonesia
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- CanSino Biologics Inc.
Dengue Fever
A Study in Children and Teenagers to Learn if a TDV Dengue Vaccination Lowers the Chance of Hospital Stays for Dengue
The main aim of this study is to collect more information on the effectiveness of TDV when used in a pilot public vaccination program for children and adolescents participating in a community-based cohort in Southeast Asian…
- Trial name
- NCT06843226
- Testing
- No Intervention
- Where
- 7 sites in Indonesia, Malaysia and 1 more
- Volunteers
- 70,000 people, healthy volunteers welcome
- Sponsor
- Takeda
Defect of Articular Cartilage
HyaloFAST Trial for Repair of Articular Cartilage in the Knee
The purpose of this study is to evaluate the safety and efficacy of Hyalofast® scaffold with bone marrow aspirate concentrate (BMAC) compared to microfracture in the treatment of symptomatic cartilage defects of the knee.
- Trial name
- FastTRACK (NCT02659215)
- Testing
- Hyalofast, Microfracture
- Where
- 48 sites in United States, Austria and 7 more
- Volunteers
- 200 people
- Sponsor
- Anika Therapeutics, Inc.
Heat Stress, Athletic Performance
Effectiveness of Topical Menthol as A Cooling Method During Exercise in A Recreational Runner Population
The goal of this clinical trial is to evaluate the effectiveness of topical menthol as a cooling method during exercise in a hot air environment in healthy adult recreational runners aged 18 to 45 years.
- Trial name
- NCT07482046
- Testing
- Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.
- Where
- Indonesia
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- Taisho Pharmaceutical Indonesia
Ankle Sprain, Back Pain
Counterpain PXM Versus Diclofenac Versus Piroxicam
The goal of this clinical trial is to learn if a gel containing Piroxicam plus Counterirritant (warming/cooling ingredients) is as effective and safe as two other common anti-inflammatory gels for treating acute muscle, bone, and…
- Conditions
- Ankle Sprain, Back Pain, Osteoarthritis (OA) of the Knee, Tennis Elbow
- Trial name
- NCT07475663
- Testing
- Piroxicam plus Counterirritant (brand name Counterpain® PXM)., Diclofenac Sodium 10 mg (Brand Name Hotin® DCL), Piroxicam 0.5% (Brand name Pirofel® gel)
- Where
- Indonesia
- Volunteers
- 180 people
- Sponsor
- Taisho Pharmaceutical Indonesia
Coronary Arterial Disease (CAD)
Clinical Investigation for Everolimus Drug Eluting Stent
History of Device Development and Study Rationale: Drug-eluting stents (DES) revolutionized percutaneous coronary intervention (PCI) by significantly reducing restenosis and the need for repeat procedures compared to bare-metal…
- Trial name
- EverGreen (NCT06769217)
- Testing
- Drug Eluting Coronary Stent
- Where
- 5 sites in India, Indonesia
- Volunteers
- 888 people
- Sponsor
- Frisch Medical Device Private Limited
Frailty in Older Adults
Allogeneic Human Mesenchymal Stem Cell Infusion for Frailty Patient
Subjects will be provided a written informed consent to participate in the study and then undergo any screening. Subjects who meet all the inclusion criteria and none of the exclusion criteria based on the screening test results…
- Trial name
- NCT07449364
- Testing
- Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC)
- Where
- Indonesia
- Volunteers
- 10 people
- Sponsor
- Daewoong Group Indonesia
Acute Respiratory Distress Syndrome
Mesenchymal Stem Cells (MSCs) and Conditioned Medium Mesenchymal Stem Cells as Adjuvant Therapy for Sepsis
This study was conducted to determine the effect of Umbilical Cord Mesenchymal Stem Cell (UC-MSC) and Secretome in severe ARDS patients.
- Trial name
- NCT07439848
- Testing
- Control (NaCl 0.9%), UC-MSC, UC-MSC and Secretome
- Where
- Indonesia
- Volunteers
- 15 people
- Sponsor
- PT. Prodia Stem Cell Indonesia