Clinical trials: Viral Hepatitis C
Chronic Hepatitis C
Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)
This study is being done to evaluate the efficacy and safety of the drug combination grazoprevir (GZR; MK-5172) + elbasvir (EBR; MK-8742) in participants with chronic hepatitis C virus (HCV) genotype (GT) 1, 4, or 6 infection and…
- Trial name
- NCT02115321
- Testing
- Grazoprevir, Elbasvir, MK-5172A
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C, Chronic
Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6
The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV…
- Trial name
- ATOMIC (NCT01329978)
- Testing
- Sofosbuvir, RBV, PEG
- Where
- 46 sites in United States, Puerto Rico
- Volunteers
- 332 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected…
- Trial name
- NCT01358864
- Testing
- BI 201335, Pegylated Interferon-alpha (IFN), Ribavirin (RBV)
- Where
- 116 sites in United States, Austria and 10 more
- Volunteers
- 678 people
- Sponsor
- Boehringer Ingelheim
Liver Transplantation, Hepatitis C, Chronic
Effects of Pegylated Interferon Alfa-2b and Ribavirin After Orthotopic Liver Transplantation in Subjects With Chronic Hepatitis C Recurrence (P04590AM3)(COMPLETED)
This is an exploratory study and is a Phase 3, single-arm, multi-center, open-label study of pegylated interferon alfa-2b, PEG-IFN alpha-2b (PEG-Intron) and ribavirin (RBV) to determine the sustained virologic response (SVR) at…
- Conditions
- Liver Transplantation, Hepatitis C, Chronic, Liver Cirrhosis
- Trial name
- NCT00378599
- Testing
- Combination of (a) pegylated interferon alfa-2b and (b) rebetol
- Volunteers
- 125 people
- Sponsor
- Merck Sharp & Dohme LLC
De Novo Kidney Transplant
MYPROMS-ES02: Safety and Efficacy of Basiliximab, Cyclosporine Microemulsion and Enteric-coated Mycophenolate Sodium (EC-MPS) Versus EC-MPS and Steroid Therapy in Kidney Transplant Recipients Who Are Hepatitis C Positive
To prospectively evaluate in de novo kidney transplant recipients, hepatitis C positive, the clinical outcomes of an immunosuppressive regimen of EC-MPS free of steroids in comparison with a regimen of EC-MPS with standard…
- Trial name
- NCT00284921
- Testing
- Enteric-coated Mycophenolate sodium (EC-MPS)
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
HCV Infection
Evaluation of Safety, Tolerability, and Immunogenicity Study of GLS-6150 in Healthy Volunteers and in Persons Previously Treated for Hepatitis C Virus Infection
Hepatitis C virus (HCV) is an enveloped, single strand, positive sense RNA flavivirus. Infection by HCV is typically chronic, although an estimated ~10-20% may spontaneously clear the virus.
- Trial name
- NCT03674125
- Testing
- GLS-6150
- Where
- 2 sites in South Korea
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- GeneOne Life Science, Inc.
Hepatitis C, HCV
TD-6450 MAD Study in HCV Infected Subjects
This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.
- Trial name
- NCT02116543
- Testing
- TD-6450
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Theravance Biopharma
Hepatitis C, Chronic
Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of VGX-6150 for Second-line Therapy of Chronic Hepatitis C Infection
To evaluate the safety, tolerability and immunogenicity of VGX-6150 as second-line therapy in chronic hepatitis C patients
- Trial name
- VGX-6150-01 (NCT02027116)
- Testing
- VGX-6150
- Where
- 2 sites in South Korea
- Volunteers
- 18 people
- Sponsor
- GeneOne Life Science, Inc.
Chronic Hepatitis C
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C infection. Given the likelihood of co administration of filibuvir and methadone, this study will evaluate the effect of filibuvir on the…
- Trial name
- NCT01210404
- Testing
- filibuvir
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Pfizer
Hepatitis C
Long-Term Follow-Up Safety Monitoring of Patients Dosed in the First-in-Man Phase I/II Study of TT-034.
This is a long-term safety follow-up protocol for subjects who received TT-034 under the B2801001 protocol and consists of monitoring for at least 4.5 years.
- Trial name
- NCT02315638
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Tacere Therapeutics, Inc.
Hepatitis C, Chronic
PHOENIX Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) and COPEGUS (Ribavirin) Administered After Liver Transplantation for Hepatitis C.
This 2-arm study was designed to evaluate the efficacy, safety, and tolerability of prophylactic PEGASYS plus COPEGUS after liver transplantation for hepatitis C, compared to initiation of antiviral therapy at the time of…
- Trial name
- NCT00087633
- Testing
- peginterferon alfa-2a [Pegasys], Copegus
- Where
- 28 sites in United States
- Volunteers
- 115 people
- Sponsor
- Hoffmann-La Roche
Hepatitis C Virus Infection
Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor
The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of…
- Trial name
- POLARIS-4 (NCT02639247)
- Testing
- SOF/VEL/VOX, SOF/VEL
- Where
- 78 sites in United States, Australia and 6 more
- Volunteers
- 333 people
- Sponsor
- Gilead Sciences
Hepatitis C, Chronic
Boceprevir/Peginterferon/Ribavirin for Chronic Hepatitis C: Erythropoietin Use Versus Ribavirin Dose Reduction for Anemia (P06086 AM2)
The current trial is designed to prospectively explore the safety of erythropoietin use for the treatment of anemia during boceprevir plus peginterferon alfa-2b/Ribavirin (PEG2b/RBV) therapy and to assess its relationship to…
- Trial name
- NCT01023035
- Testing
- Boceprevir, Peginterferon alfa-2b (PEG2b), Ribavirin (RBV)
- Volunteers
- 687 people
- Sponsor
- Merck Sharp & Dohme LLC
Hepatitis C Viral Infection, Chronic Hepatitis C
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in treatment-naïve participants with genotype…
- Conditions
- Hepatitis C Viral Infection, Chronic Hepatitis C, Hepatitis C (HCV), Hepatitis C Genotype 1
- Trial name
- NCT02716428
- Testing
- Faldaprevir, TD-6450, Ribavirin
- Where
- 6 sites in United States, New Zealand
- Volunteers
- 25 people
- Sponsor
- Trek Therapeutics, PBC
Hepatitis C, Chronic
Effect of Infliximab on the Efficacy of Peg-Intron/Ribavirin in Patients With Hepatitis C (Study P04257AM4)(COMPLETED)
This is a Phase IIIB, randomized, prospective, multicenter, single-country, open-label, controlled pilot trial designed to evaluate the effect of infliximab induction therapy on sustained virologic response (SVR) to treatment…
- Trial name
- Pegade (NCT00237484)
- Testing
- Induction dose of (a) infliximab followed by combination of (b) pegylated interferon alfa-2b and (c) ribavirin, Combination of (a) pegylated interferon alfa-2b and (b) ribavirin
- Volunteers
- 89 people
- Sponsor
- Merck Sharp & Dohme LLC
Whole Cell Pertussis, Haemophilus Influenzae Type b
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of…
- Conditions
- Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Diphtheria
- Trial name
- NCT00136604
- Testing
- Tritanrix-HepB/Hib-MenAC, Mencevax ACWY, Tritanrix-HepB/Hiberix
- Where
- 3 sites in Thailand
- Volunteers
- 617 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis C
Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)
The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.
- Trial name
- FOURward (NCT02175966)
- Testing
- DCV/ASV/BMS-791325, Ribavirin, Sofosbuvir
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis C
Study to Determine the Potential DDIs When the Daclatasvir/Asunaprevir/BMS-791325 Three Drug Antiviral Combination Tablet (FDC) is Coadministered With a Cocktail of Cytochrome P450 (CYP) Probe Substrates and Transporter Probe Substrates (Digoxin and Pravastatin) in Healthy Subjects
The primary purpose of this study is to assess the effect of the Daclatasvir/Asunaprevir/BMS-791325 fixed dose combination (FDC) tablet on the pharmacokinetics of the cocktail CYP and transporter probe substrates and to assess…
- Trial name
- NCT02045966
- Testing
- Cocktail, DCV 3DAA FDC, BMS-791325
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
HIV/HCV Coinfection
Pegasys Long-Term Anti-Fibrotic Effect Co-Infection Trial (PERFECT)
This is an uncontrolled, open-label, Phase III trial of peginterferon alfa-2a (Pegasys) in participants coinfected with human immunodeficiency virus (HIV) and hepatitis C virus (HCV).
- Trial name
- NCT02762383
- Testing
- Peginterferon Alfa-2
- Where
- 10 sites in Belgium
- Volunteers
- 19 people
- Sponsor
- Hoffmann-La Roche
Self Efficacy, Hepatitis C
Y- Shaped Pegylated Interferon (YPEG-IFNα-2a) Plus Ribavirin in Egyptian Patients With Untreated Chronic Hepatitis C
The objective is to assess the efficacy, dosing, safety and tolerance of Y- shaped pegylated interferon (YPEG-IFNα-2a) plus ribavirin in Egyptian patients with chronic hepatitis C and with no prior treatment for hepatitis C virus…
- Trial name
- NCT01327729
- Testing
- pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg
- Where
- Egypt
- Volunteers
- 300 people
- Sponsor
- BioGeneric Pharma
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