Clinical trials: Hepatitis b Virus
Hepatitis B
Safety and Immunogenicity Following Recombinant Hepatitis B (Bio Farma) Vaccine in Adults & Children
This trial is an experimental, randomized, double blind, prospective intervention study Approximately 100 subjects will be enrolled in this trial, divided into 2 arms, as follow: For adult (18-40 years old)
- Trial name
- NCT04188223
- Testing
- Recombinant Hepatitis B (Bio Farma) Vaccine, Recombinant Hepatitis B (Bio Farma) Vaccine®
- Where
- Indonesia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- PT Bio Farma
Chronic Hepatitis C Virus (HCV) Infection Genotype 1
A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection
The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic…
- Trial name
- TOPAZ-II (NCT02167945)
- Testing
- ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
- Where
- 48 sites in United States
- Volunteers
- 615 people
- Sponsor
- AbbVie
Hepatitis C Virus (HCV)
A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation
The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the…
- Trial name
- DETI-2 (NCT04189627)
- Where
- 8 sites in Russia
- Volunteers
- 99 people
- Sponsor
- AbbVie
Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18
Immunogenicity and Safety of Co-immunization With Cecolin and Hecolin
The purpose of this study is to evaluate the immunogenicity and safety of co-immunization with recombinant human papillomavirus bivalent (Types 16,18) vaccine (Escherichia coli) and Hepatitis E vaccine (Escherichia coli)
- Conditions
- Human Papilloma Virus Infection Type 16, Human Papilloma Virus Infection Type 18, Hepatitis E Virus Infection
- Trial name
- NCT05415345
- Testing
- Cecolin, Hecolin
- Where
- China
- Volunteers
- 480 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis C Virus (HCV)
Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis
Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged.
- Trial name
- EASY (NCT04352309)
- Where
- 6 sites in Russia
- Volunteers
- 99 people
- Sponsor
- AbbVie
Hepatitis C, Hepatitis C, Chronic
Study of AT-777 in Healthy Subjects and AT-777 in Combination With AT-527 in HCV-Infected Subjects
This study has two parts. Part A will assess the safety, tolerability and pharmacokinetics (PK) of AT-777 in healthy subjects. Part B will assess the safety, antiviral activity/efficacy and PK of AT-777 in combination with AT-527…
- Conditions
- Hepatitis C, Hepatitis C, Chronic, Chronic Hepatitis C, Hepatitis C Virus Infection
- Trial name
- NCT04309734
- Testing
- AT-777, AT-527
- Where
- Belgium
- Volunteers
- healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Hepatitis C Virus Infection
Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study
The purpose of this study was to evaluate the efficacy and safety of co-administration of glecaprevir (ABT-493)/pibrentasvir (ABT 530) plus sofosbuvir (SOF) plus ribavirin (RBV) in hepatitis C virus (HCV) genotype (GT) 1 …
- Trial name
- MAGELLAN-3 (NCT02939989)
- Testing
- Sofosbuvir, Glecaprevir/Pibrentasvir, Ribavirin
- Where
- 26 sites in United States, Australia and 10 more
- Volunteers
- 33 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in adults with chronic hepatitis C virus (HCV)…
- Trial name
- NCT04112303
- Testing
- SOF/VEL
- Where
- 22 sites in Japan
- Volunteers
- 37 people
- Sponsor
- Gilead Sciences
Diphtheria, Tetanus
DTaP-IPV-HB-PRP-T Combined Vaccine as a Primary Series and a Second Year of Life Booster in HIV-Exposed Infected and Uninfected Infants
This study aims to assess and confirm the adequate immunogenicity and safety profile of the Sanofi Pasteur's DTaP-Hep B-IPV-PRP-T fully liquid combined hexavalent vaccine administered in HIV-exposed uninfected infants and in…
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B
- Trial name
- NCT02817451
- Testing
- Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine
- Where
- South Africa
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Chronic Hepatitis B Virus Infection
A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC HEPATITIS B VIRUS INFECTION.
Part 1 is a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of EDP-721 in healthy subjects.
- Trial name
- NCT04971512
- Testing
- EDP-721, EDP-721 (Part 2), EDP-514
- Where
- New Zealand
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Enanta Pharmaceuticals, Inc
Chronic Hepatitis C Virus Infection
Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection
Primary objective: To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W +…
- Trial name
- NCT04382937
- Testing
- P1101 + Ribavirin, PEG-Intron + Ribavirin
- Where
- 39 sites in China, South Korea and 1 more
- Volunteers
- 222 people
- Sponsor
- PharmaEssentia
Hepatitis C Virus
Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea
The objectives of this study are to collect and assess data related to safety and effectiveness of Sovaldi treatment regimens, per the approved prescribing information for Sovaldi, in routine clinical practice and report results…
- Trial name
- NCT02907996
- Testing
- Sofosbuvir
- Where
- 72 sites in South Korea
- Volunteers
- 2,033 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
The Durability of Response and Persistence of Resistance to AbbVie's 2 Direct-acting Antiviral Agent (2D) Therapy in Japanese Subjects
This study seeks to assess the durability of response and persistence of resistance to ombitasvir/ paritaprevir/ritonavir in Japanese participants who enrolled in a Phase 2 or 3 clinical study with these agents for the treatment…
- Trial name
- NCT02581020
- Where
- 53 sites in Japan
- Volunteers
- 344 people
- Sponsor
- AbbVie
Hepatitis C Virus
Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea
The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea…
- Trial name
- NCT02951364
- Testing
- LDV/SOF
- Where
- 72 sites in South Korea
- Volunteers
- 1,081 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus Infection
Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection
The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir…
- Trial name
- NCT04211909
- Testing
- SOF/VEL, SOF/VEL/VOX
- Where
- 22 sites in South Korea
- Volunteers
- 87 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus (HCV)
Glecaprevir/Pibrentasvir Drug Use Results Survey in Patients Infected With Hepatitis C Virus Genotype 1-6
This multi-center, post-marketing, observational study evaluates the real world safety and effectiveness of glecaprevir plus pibrentasvir use in participants infected with the hepatitis C virus genotype 1 - 6.
- Trial name
- NCT03341871
- Where
- Japan
- Volunteers
- 1,095 people
- Sponsor
- AbbVie
Hepatitis C Virus
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based…
- Trial name
- GIFT-II (NCT02023112)
- Testing
- ABT-450/r/ABT-267, Ribavirin
- Volunteers
- 171 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Co-Administration of ABT-493 and ABT-530 With and Without RBV in Subjects With Chronic Hepatitis C Virus (HCV) Genotypes 2, 3, 4, 5 or 6 Infection
The purpose of this phase 2/3, open-label, multipart, multicenter study was to evaluate the efficacy, and safety of co-administration of ABT-493 and ABT-530 with and without ribavirin (RBV) in chronic HCV genotype 2 (GT2-)…
- Trial name
- NCT02243293
- Testing
- ABT-493, ABT-530, ribavirin (RBV)
- Volunteers
- 694 people
- Sponsor
- AbbVie
Hepatitis C Infection, Hepatitis C Virus
A Study to Evaluate Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Treatment-Naïve Hepatitis C Virus Genotype 1b-Infected Adults
This study will evaluate the safety and efficacy of ombitasvir/paritaprevir/ ritonavir and dasabuvir administered for 8 weeks in treatment-naïve participants with genotype 1b (GT1b) hepatitis C virus (HCV).
- Trial name
- GARNET (NCT02582632)
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir
- Volunteers
- 166 people
- Sponsor
- AbbVie
Chronic Hepatitis C, Hepatitis C Virus
A Study Comparing Efficacy and Safety of ABT-493/ABT-530 to Sofosbuvir Dosed With Daclatasvir in Adults With HCV Genotype 3 Infection
The purpose of this study was to compare the safety and efficacy of ABT-493/ABT-530 to the combination of sofosbuvir (SOF) and daclatasvir (DCV) in adults with genotype 3 (GT3) chronic hepatitis C virus (HCV) infection.
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Genotype 3 Hepatitis C Virus
- Trial name
- ENDURANCE-3 (NCT02640157)
- Testing
- ABT-493/ABT-530, Sofosbuvir, Daclatasvir
- Volunteers
- 506 people
- Sponsor
- AbbVie