Clinical trials: HCV Infection
Hepatitis C Virus (HCV)
A Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Glecaprevir/Pibrentasvir in Pediatric Subjects With Genotypes 1-6 Chronic Hepatitis C Virus (HCV) Infection
The objectives of this study are to assess the pharmacokinetics, safety, and efficacy of glecaprevir/pibrentasvir adult formulation in adolescents ages 12 to 17 years and a pediatric formulation of glecaprevir and pibrentasvir in…
- Trial name
- DORA (NCT03067129)
- Testing
- Glecaprevir/Pibrentasvir Adult Formulation, Glecaprevir + Pibrentasvir Pediatric Formulation
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 129 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL)…
- Trial name
- NCT03022981
- Testing
- SOF/VEL
- Where
- 27 sites in United States, Belgium and 2 more
- Volunteers
- 216 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus
Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir
The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a…
- Trial name
- PEDESTAL (NCT01598090)
- Testing
- Peginterferon Lambda-1a, Peginterferon Alfa-2a, Ribavirin
- Where
- 104 sites in United States, Austria and 13 more
- Volunteers
- 881 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Virus Infection
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection
The primary objective of the PK Lead-in Phase of the study is to evaluate the steady state pharmacokinetics (PK) and confirm the dose of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) in hepatitis C virus…
- Trial name
- NCT02249182
- Testing
- LDV/SOF, RBV
- Where
- 31 sites in United States, Australia and 2 more
- Volunteers
- 226 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic Hepatitis
Evaluation of Daclatasvir (DCV) in Combination With Sofosbuvir (SOF) in Children With Chronic Hepatitis C (CHC) Infection
The purpose of this study is to evaluate daclatasvir in combination with sofosbuvir given to children with chronic hepatitis C infection
- Trial name
- NCT03487848
- Testing
- Daclatasvir, Sofosbuvir
- Where
- 2 sites in Australia, Spain
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C Virus (HCV)
Study of Oral Glecaprevir/Pibrentasvir Tablets in Participants Aged 12 Years or Older With Chronic Hepatitis C to Assess Sustained Virological Response
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
- CHOICE (NCT04577482)
- Where
- 10 sites in Russia
- Volunteers
- 42 people
- Sponsor
- AbbVie
Chronic Hepatitis C
Efficacy and Safety of Boceprevir in Combination With Peginterferon Alfa-2b Plus Ribavirin in Pediatric Subjects With Chronic Hepatitis C Genotype 1 (P08034)
This is a three-part (Part A, Part B, and Part C), open-label, multicenter study of boceprevir in pediatric participants with chronic hepatitis C (CHC) genotype 1 (GT1).
- Trial name
- NCT01590225
- Testing
- Boceprevir, Peginterferon alpha-2b, Ribavirin
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C
A Registration Study to Evaluate the Performance of CHIRON® RIBA® HCV 3.0 SIA in HCV Antibody Detection
To evaluate the accuracy of the CHIRON® RIBA® HCV 3.0 (RIBA, Investigational Product) test using known anti-HCV seropositive and seronegative specimens. Registration for license application
- Trial name
- NCT01582594
- Where
- 4 sites in China
- Volunteers
- 795 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Medical, China
HIV Infections, Hepatitis B Infections
Rapid Diagnostics for HIV and Hepatitis
The purpose of this study is to determine the efficacy of two rapid diagnostic tests in plasma, venipuncture whole blood, and fingerstick whole blood.
- Conditions
- HIV Infections, Hepatitis B Infections, Hepatitis C Infections
- Trial name
- NCT02190305
- Testing
- Multiplo HBc/HIV/HCV and Reveal HBsAg
- Where
- 4 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Chronic Hepatitis C
Long-Term Extension Study of Miravirsen Among Participants With Genotype 1 Chronic Hepatitis C (CHC) Who Have Not Responded to Pegylated-Interferon Alpha Plus Ribavirin
Genotype 1 CHC participants from Study SPC3649-207 with null response to prior pegylated-interferon alpha plus ribavirin will be enrolled into this 36-month extension study, designed to evaluate the long-term safety and efficacy…
- Trial name
- NCT02508090
- Where
- Puerto Rico
- Volunteers
- 10 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus
A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1
To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.
- Trial name
- UNITY 4 (NCT02170727)
- Testing
- DCV/ASV/BMS-791325
- Where
- 20 sites in Russia, South Korea and 1 more
- Volunteers
- 199 people
- Sponsor
- Bristol-Myers Squibb
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 (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
Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)
This is a three-year (except for participants with chronic kidney disease [CKD] or cirrhosis) multicenter study to follow participants who received at least one dose of grazoprevir (MK-5172) in a previous study to determine…
- Trial name
- NCT01667081
- Testing
- Grazoprevir
- Volunteers
- 2,438 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Virus Infection
A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials
This Registry will enroll adolescent and pediatric participants who received at least one Gilead Hepatitis C Virus (HCV) direct acting antiviral (DAA) while participating in a Gilead-sponsored chronic hepatitis C clinical trial.
- Trial name
- NCT02510300
- Testing
- Sofosbuvir (SOF), Ledipasvir/Sofosbuvir (LDV/SOF), Sofosbuvir/Velpatasvir (SOF/VEL)
- Where
- 51 sites in United States, Australia and 7 more
- Volunteers
- 461 people
- Sponsor
- Gilead Sciences
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
Hepatitis C, Chronic, Hepatitis C
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C.
- Trial name
- NCT00724230
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 505 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic, Hepatitis C
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol.
- Trial name
- APEGIN (NCT00724854)
- Testing
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- Volunteers
- 1,146 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C.
- Trial name
- NCT00104052
- Testing
- peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908)
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
5 Year Long-term Follow up in Pediatric Participants Who Received PegIntron Plus Rebetol in P02538 Part I (P02538 Pt 2)
Study P02538 Part 2 is a 5-year long term follow-up (LTFU) study in pediatric participants who were treated with at least one dose of peginterferon alfa-2b (PEG-IFN) and ribavirin (RBV) and who completed the follow-up in the…
- Trial name
- NCT00761735
- Testing
- Peginterferon alfa-2b, Ribavirin
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC