Clinical trials: in India
Healthy
PK, PD, Safety & Immunogenicity of ADL-018 Lyo in Healthy Adult Subjects
This will be a randomized, double blind, two-arm, single dose, parallel group, PK, PD and safety and immunogenicity study in healthy, adult, subjects.
- Trial name
- NCT05564611
- Testing
- Omalizumab 150mg
- Where
- India
- Volunteers
- 204 people, healthy volunteers welcome
- Sponsor
- Kashiv BioSciences, LLC
Chronic Idiopathic Urticaria
Study to Compare Efficacy Safety and Immunogenicity of ADL-018 With XOLAIR (Omalizumab) in Adults With Chronic Idiopathic Urticaria
The purpose of the study is to compare the efficacy, safety, tolerability, and immunogenicity of ADL-018 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1…
- Trial name
- NCT05774639
- Testing
- Omalizumab Injection, Xolair Prefilled Syringe
- Where
- 6 sites in United States, India and 1 more
- Volunteers
- 600 people
- Sponsor
- Kashiv BioSciences, LLC
Coronavirus Disease-2019 (COVID-19) Prevention
A Study to Evaluate Different Dose Levels of Ad26.COV2.S in Healthy Adolescents From 12 to 17 Years Inclusive
The primary purpose of this study is to assess the safety, reactogenicity, and humoral immune response of Ad26.COV2.S administered intramuscularly (IM) as a 1-dose schedule or as a 2-dose schedule (56-day interval) in adolescents.
- Trial name
- HORIZON 2 (NCT05007080)
- Testing
- Ad26.COV2.S
- Where
- 18 sites in Argentina, Brazil and 3 more
- Volunteers
- 304 people, healthy volunteers welcome
- Sponsor
- Janssen Vaccines & Prevention B.V.
Adult Relapsed/Refractory B Cell Acute Lymphoblastic Leukemia
A Study of Patients Who Received Inotuzumab Ozogamicin for B-cell ALL (Acute Lymphoblastic Leukemia) That Occurred Again After the Last Treatment
The purpose of the study was to understand the effectiveness and safety of the study medicine called Inotuzumab ozogamicin (InO) in patients with B-cell ALL in whom the disease occurred again after the last treatment.
- Trial name
- NCT05597085
- Testing
- Inotuzumab Ozogamicin
- Where
- 5 sites in India
- Volunteers
- 32 people
- Sponsor
- Pfizer
Influenza A
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Non-Hospitalized Participants With Influenza A Infection Who Are at Risk of Developing Complications
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
- Trial name
- NCT03381196
- Testing
- Pimodivir 600 mg, SOC Treatment
- Where
- 427 sites in United States, Argentina and 36 more
- Volunteers
- 553 people
- Sponsor
- Janssen Research & Development, LLC
Spondylitis, Ankylosing, Arthritis, Psoriatic
A Study of Golimumab in the Treatment of Indian Participants With Active Spondyloarthropathy of Ankylosing Spondylitis or Psoriatic Arthritis
The purpose of this study is to assess the safety of subcutaneous (SC) golimumab in participants with active Ankylosing Spondylitis (AS) or Psoriatic Arthritis (PsA) over 24 weeks.
- Trial name
- NCT03733925
- Testing
- Golimumab
- Where
- 9 sites in India
- Volunteers
- 100 people
- Sponsor
- Johnson & Johnson Private Limited
Influenza A
A Study to Evaluate the Efficacy and Safety of Pimodivir in Combination With the Standard-of-Care Treatment in Adolescent, Adult, and Elderly Hospitalized Participants With Influenza A Infection
The purpose of this study is to evaluate the clinical and virologic benefit of pimodivir in combination with Standard-of-Care (SOC) treatment compared to placebo in combination with SOC treatment.
- Trial name
- NCT03376321
- Testing
- Pimodivir 600 mg, SOC Treatment
- Where
- 269 sites in United States, Argentina and 36 more
- Volunteers
- 334 people
- Sponsor
- Janssen Research & Development, LLC
Prostate Cancer
A Post-marketing Surveillance to Assess Safety of Abiraterone Acetate (Zytiga) in Indian Participants With Metastatic, Castration Resistant Prostate Cancer
The purpose of this study is to evaluate the safety of abiraterone acetate in Indian participants with metastatic, castration-resistant prostate cancer who have been prescribed abiraterone acetate as per locally approved…
- Trial name
- NCT02608359
- Testing
- Abiraterone Acetate
- Where
- 3 sites in India
- Sponsor
- Johnson & Johnson Private Limited
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
Clinical Outcomes of Chronic Lymphocytic Leukemia (CCL) and Mantle Cell Lymphoma (MCL) Participants Treated With Ibrutinib: A Medical Chart Review From India
The purpose of this study is to describe the effectiveness (overall response rate [ORR] and time to progression [TPP]) of Ibrutinib therapy in participants with chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL).
- Trial name
- NCT03476655
- Testing
- Ibrutinib
- Where
- 8 sites in India
- Volunteers
- 40 people
- Sponsor
- Johnson & Johnson Private Limited
Multiple Myeloma
A Study of DARZALEX (Daratumumab) In Indian Participants With Relapsed and Refractory Multiple Myeloma, Whose Prior Therapy Included a Proteasome Inhibitor and an Immunomodulatory Agent
The purpose of this study is to demonstrate the safety profile of daratumumab in routine clinical practice when given as monotherapy in Indian participants with relapsed and refractory multiple myeloma, whose prior therapy…
- Trial name
- NCT03768960
- Testing
- Daratumumab
- Where
- 16 sites in India
- Volunteers
- 150 people
- Sponsor
- Johnson & Johnson Private Limited
Meningococcal Immunization, Healthy Volunteers
Immunogenicity and Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine in Healthy Adults, Adolescents, Children, and Toddlers in India and Healthy Adolescents and Children in the Republic of South Africa
This will be a Phase III, modified double-blind (open-label for toddlers in India), randomized, parallel-group, active-controlled, step-wise, multi-center study to compare and describe the immunogenicity and safety of MenACYW…
- Trial name
- MET55 (NCT04143061)
- Testing
- Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine, Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine
- Where
- 17 sites in India, South Africa
- Volunteers
- 1,328 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Aging
A Study to Evaluate Efficacy of Dietary Ingredient in Vitality and Metabolic Factors in Healthy Individuals
The present study is a randomized, placebo-controlled, feasibility study to evaluate efficacy of dietary ingredients in vitality \& metabolic factors in healthy individuals.
- Trial name
- NCT06188949
- Testing
- Dolichos biflorus (Horsegram) seed extract, Carica papaya leaves extract
- Where
- 2 sites in India
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Mood and Sleep Quality
A Study to Evaluate the Efficacy of VL-NL-02 on Sleep Quality.
The goal of this clinical trial is to study the impact of VL-NL-02 in improving sleep quality, restorative sleep complaints, quality of life, stress levels, and sleep stages.
- Trial name
- NCT06056258
- Testing
- VL-NL-02
- Where
- 5 sites in India
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Vedic Lifesciences Pvt. Ltd.
Non Alcoholic Steatohepatitis (NASH)
Efficacy, Safety and Tolerability of the Combination of Tropifexor & Licogliflozin and Each Monotherapy, Compared With Placebo in Adult Patients With NASH and Liver Fibrosis.
Randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor \& licogliflozin combination therapy and each monotherapy, compared with placebo for treatment of adult…
- Trial name
- ELIVATE (NCT04065841)
- Testing
- Tropifexor, Licogliflozin
- Where
- 80 sites in United States, Argentina and 22 more
- Volunteers
- 234 people
- Sponsor
- Novartis Pharmaceuticals
Intestinal Diseases
Bioequivalence Study Between Two Albendazole 400 mg Tablets in Healthy Adult Participants Under Fed Conditions
The goal of this study is to compare two formulations of Albendazole of the same dose in healthy adult participants. Researchers will compare the extent and rate to which the drug is absorbed.
- Trial name
- NCT06201559
- Testing
- Albendazole IP 400 mg, Albendazole 400 mg
- Where
- India
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Prostate Cancer
Study of Capivasertib + Docetaxel vs Placebo + Docetaxel as Treatment for Metastatic Castration Resistant Prostate Cancer (mCRPC)
This study will assess the efficacy and safety of capivasertib plus docetaxel versus placebo plus docetaxel in participants with metastatic castration resistant prostate cancer (mCRPC), all participants will receive the docetaxel…
- Trial name
- CAPItello280 (NCT05348577)
- Testing
- capivasertib, docetaxel
- Where
- 217 sites in United States, Australia and 20 more
- Volunteers
- 1,035 people
- Sponsor
- AstraZeneca
Infertility
Efficacy and Safety of FE 999049 in Controlled Ovarian Stimulation in Indian Women
To demonstrate non-inferiority of FE 999049 compared with GONAL-F with respect to ongoing pregnancy rate in women undergoing controlled ovarian stimulation.
- Trial name
- IRIS (NCT04773353)
- Testing
- Follitropin Delta (FE 999049), Follitropin Alfa (GONAL-F)
- Where
- 12 sites in India
- Volunteers
- 220 people
- Sponsor
- Ferring Pharmaceuticals
Hunter Syndrome
A Study of Elaprase in Children and Adults With Hunter Syndrome (Mucopolysaccharidosis II) in India
The main aim of this study is to learn more about the safety profile of Elaprase in Indian children and adults with hunter syndrome.
- Trial name
- NCT05058391
- Testing
- Elaprase
- Where
- 5 sites in India
- Volunteers
- 5 people
- Sponsor
- Takeda
Bioavailability
CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting Conditions
The objective of this study is to evaluate the oral bioavailability of 'CreNeuroS CNS Fish Oil Plus Softgels [Eicosapentaenoic Acid (as Ethyl Ester) 342 mg; L-5-methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals] (Test…
- Trial name
- BE-001-2024 (NCT06758778)
- Testing
- CreNeuroS CNS Fish Oil Plus Softgel [380 mg of fish oil contains Eicosapentaenoic Acid (EPA) （as EE）342 mg; L-5- Methyltetrahydrofolate 1.875 mg; other Vitamins and Minerals], Vascepa® (Icosapent ethyl) 1000 mg Capsules, Deplin® (L-methylfolate Calcium) 7.5 mg Capsules
- Where
- India
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Sichuan Credit Pharmaceutical Co., Ltd.
Chronic Kidney Diseases, Anemia of Chronic Kidney Disease
A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)
A Phase 4, 52 week, single arm, multicentre post marketing surveillance to evaluate the safety of Desidustat for the treatment of anemia in subjects with chronic kidney disease (CKD)
- Trial name
- NCT05515367
- Testing
- Desidustat
- Where
- India
- Volunteers
- 1,004 people
- Sponsor
- Zydus Lifesciences Limited
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