Clinical trials: Cirrhosis Infectious
Chronic Hepatitis C, Decompensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
The primary objectives of this study are to assess the safety and the SVR12 rate of ombitasvir/paritaprevir/ritonavir and dasabuvir with RBV in GT1-infected participants with decompensated cirrhosis.
- Conditions
- Chronic Hepatitis C, Decompensated Cirrhosis, Hepatitis C Virus
- Trial name
- TURQUOISE-CPB (NCT02219477)
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, ribavirin
- Volunteers
- 36 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Ledipasvir/Sofosbuvir Fixed-Dose Combination and Vedroprevir With or Without Ribavirin in Treatment-Experienced Participants With Chronic Genotype 1 HCV Infection and Cirrhosis
This study is to evaluate the antiviral efficacy, safety, and tolerability of combination therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) + vedroprevir (VDV) ± ribavirin (RBV) for 8 weeks in…
- Trial name
- NCT02226549
- Testing
- LDV/SOF, VDV, RBV
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus (HCV)
A Study to Evaluate the Efficacy and Safety of Glecaprevir (GLE)/Pibrentasvir (PIB) in Treatment-Naive Adults in Brazil With Chronic Hepatitis C Virus (HCV) Genotype 1 - 6 Infection
This was a Phase 3, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir (GLE)/pibrentasvir (PIB) for an 8 or 12-week treatment duration in adults in Brazil with chronic hepatitis C virus (HCV)…
- Trial name
- NCT03219216
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 14 sites in Brazil
- Volunteers
- 100 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis
The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants…
- Trial name
- NCT02994056
- Testing
- SOF/VEL, RBV
- Where
- 12 sites in United States, France
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Hepatitis C Virus (HCV)
Efficacy and Safety of Glecaprevir/Pibrentasvir (ABT-493/ABT-530) in Treatment-Naive and Treatment-Experienced Asian Adults With Chronic Hepatitis C Virus Genotype (GT) 1 to GT6 Infection With Compensated Cirrhosis and With or Without Human Immunodeficiency Virus Co-Infection
This study will evaluate the efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in chronic hepatitis C virus (HCV) genotype (GT)1 to GT6-infected Asian participants with compensated cirrhosis with or without human…
- Trial name
- VOYAGE-2 (NCT03235349)
- Testing
- Glecaprevir/Pibrentasvir
- Where
- 34 sites in China, South Korea
- Volunteers
- 160 people
- Sponsor
- AbbVie
Hepatitis C, Liver Cirrhosis
Open Label Single Dose Phase I Trial of BI 201335 to Study Pharmacokinetics and Safety in Patients With Compensated Liver Cirrhosis
This trial was intended to investigate the pharmacokinetics, safety and tolerability of BI 201335 NA soft-gel capsules in patients with compensated liver cirrhosis, i.e. grade A according to Child-Pugh classification (< 7 points).
- Trial name
- NCT01909778
- Testing
- BI 201335
- Where
- Germany
- Volunteers
- 2 people
- Sponsor
- Boehringer Ingelheim
Hepatitis C, Chronic
Telaprevir Open-Label Study in Co-Infected Patients
The purpose of this study is to collect safety and tolerability data on telaprevir treatment in combination with Peg-IFN-alfa and RBV in patients with HIV/genotype 1 chronic HCV coinfection with severe fibrosis or compensated…
- Trial name
- NCT01500616
- Testing
- Telaprevir
- Where
- 29 sites in Belgium, Germany and 6 more
- Volunteers
- 122 people
- Sponsor
- Janssen-Cilag International NV
Hepatitis, Hepatitis B, Chronic
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the…
- Conditions
- Hepatitis, Hepatitis B, Chronic, Cirrhosis
- Trial name
- NCT00076336
- Testing
- Telbivudine, Lamivudine
- Where
- 28 sites in United States, Australia and 19 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C, Chronic
A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive
The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C…
- Trial name
- NCT02993250
- Testing
- AL-335, Odalasvir (ODV), Simeprevir (SMV)
- Where
- 14 sites in Japan
- Volunteers
- 33 people
- Sponsor
- Janssen Pharmaceutical K.K.
Liver Transplant, Hepatitis C
Liver Fibrosis in Patients Transplanted for Hepatitis C Receiving Either Cyclosporine Microemulsion or Tacrolimus
Following a transplant for hepatitis C cirrhosis, the infection comes back in 70-90% of cases and over time causes fibrosis and eventually cirrhosis of the new liver.
- Trial name
- NCT00260208
- Testing
- Cyclosporine A, Tacrolimus
- Where
- 2 sites in United States, Switzerland
- Volunteers
- 361 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis C Virus Infection
Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection
The primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks with that of sofosbuvir (SOF) + ribavirin (RBV) for 24 weeks and to…
- Trial name
- ASTRAL-3 (NCT02201953)
- Testing
- SOF/VEL, SOF, RBV
- Where
- 76 sites in United States, Australia and 7 more
- Volunteers
- 558 people
- Sponsor
- Gilead Sciences
HIV, HIV-Infections
The Visceral Adiposity Measurement and Observation Study
The Visceral Adiposity Measurement and Observation Study
- Conditions
- HIV, HIV-Infections, HIV-1-infection, HIV I Infection
- Trial name
- VAMOS (NCT05383456)
- Testing
- Diagnostic Test, HIV Anti-retroviral Background Therapy
- Where
- 8 sites in United States
- Volunteers
- 196 people
- Sponsor
- Theratechnologies
Chronic Hepatitis C, Liver Fibrosis
Prevention of Disease Progress in Chronic Hepatitis C Patients With Liver Fibrosis (Study P02570AM2)(COMPLETED)
The objective of the study is to evaluate the safety and efficacy of PEG-Intron versus no treatment for the prevention of fibrosis progression in adult participants with moderate to severe liver fibrosis secondary to chronic…
- Trial name
- NCT00049842
- Testing
- peginterferon alfa-2b (SCH 54031)
- Volunteers
- 540 people
- Sponsor
- Merck Sharp & Dohme LLC
Chronic Hepatitis C, Hepatitis C Virus
Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease
This open-label study will evaluate safety, pharmacokinetics and efficacy of a 12 or 24-week regimen of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in HCV-genotype 1-infected subjects with an…
- Conditions
- Chronic Hepatitis C, Hepatitis C Virus, Compensated Cirrhosis, Severe Renal Impairment
- Trial name
- NCT02207088
- Testing
- ombitasvir/paritaprevir/ritonavir, dasabuvir, Ribavirin
- Volunteers
- 68 people
- Sponsor
- AbbVie
Chronic Hepatitis C Infection, Compensated Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir in Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Cirrhosis
The purpose of this study was to evaluate the safety and efficacy of ombitasvir/ paritaprevir/ ritonavir and dasabuvir in adults with genotype 1b chronic hepatitis C virus (HCV) infection and cirrhosis.
- Trial name
- TURQUOISE-III (NCT02219503)
- Testing
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir
- Volunteers
- 60 people
- Sponsor
- AbbVie
Hepatitis C Virus Infection
A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
The primary objective of this registry study is to assess the durability of sustained virologic response (SVR) and clinical progression or regression of liver disease including the incidence of hepatocellular carcinoma following…
- Trial name
- NCT02292706
- Testing
- Sofosbuvir, Ribavirin, LDV/SOF
- Where
- 138 sites in United States, Australia and 8 more
- Volunteers
- 1,609 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C Virus (HCV)
ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 Co-Administered With Ribavirin (RBV) in Treatment Naïve and Treatment Experienced Asian Adults With Genotype 1b Chronic Hepatitis C Virus (HCV) Infection and Compensated Cirrhosis
This is a Phase 3, open-label, multicenter study evaluating the efficacy and safety of ABT-450/r/ ABT-267 and ABT-333 coadministered with RBV for 12 weeks in HCV genotype 1b, treatment naïve and Interferon (IFN) (alpha, beta or…
- Trial name
- NCT02517528
- Testing
- ABT-450/r/ABT-267, ABT-333, ribavirin
- Volunteers
- 104 people
- Sponsor
- AbbVie
HCV Infection
Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Cirrhotic Subjects With Chronic Genotype 1 HCV Infection
This study is to determine the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) with and without ribavirin (RBV), and to evaluate the safety and tolerability of each regimen as assessed by…
- Trial name
- NCT01965535
- Testing
- LDV/SOF, RBV
- Where
- 19 sites in France
- Volunteers
- 155 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis C, Cirrhosis
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection
The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.
- Conditions
- Chronic Hepatitis C, Cirrhosis, Hepatitis C Virus
- Trial name
- NCT02442284
- Testing
- ombitasvir/paritaprevir/ritonavir and dasabuvir, Ribavirin
- Volunteers
- 99 people
- Sponsor
- AbbVie
Hepatitis C, Cirrhosis
Sofosbuvir and Ribavirin in Patients With Chronic HCV With Cirrhosis and Portal Hypertension With or Without Liver Decompensation
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection.
- Conditions
- Hepatitis C, Cirrhosis, Portal Hypertension, With or Without Liver Decompensation
- Trial name
- NCT01687257
- Testing
- SOF, RBV
- Where
- 9 sites in United States, Australia and 3 more
- Volunteers
- 50 people
- Sponsor
- Gilead Sciences