PILOT STUDY TO EVALUATE THE EFFECTS OF PARITAPREVIR/r, DASABUVIR AND OMBITASVIR ON LIVER FUNCTION AND SYSTEMIC HEMODYNAMIC IN PATIENTS WITH DECOMPENSATED HCV-CIRRHOSIS

PILOT STUDY TO EVALUATE THE EFFECTS OF PARITAPREVIR/r, DASABUVIR AND OMBITASVIR ON LIVER FUNCTION AND SYSTEMIC HEMODYNAMIC IN PATIENTS WITH DECOMPENSATED HCV-CIRRHOSIS - DECIPHER-3D

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003152-43-ES

Enrollment

Registered

2015-11-12

Start date

2016-02-04

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PILOT STUDY TO EVALUATE THE EFFECTS OF PARITAPREVIR/r, DASABUVIR AND OMBITASVIR ON LIVER FUNCTION AND SYSTEMIC HEMODYNAMIC IN PATIENTS WITH DECOMPENSATED HCV-CIRRHOSIS MedDRA version: 20.0 Level: LLT Classification code 10024667 Term: Liver cirrhosis System Organ Class: 10019805 - Hepatobiliary disorders

Interventions

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Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age between 18 and 75 year- old. - Child B cirrhosis (7-9 points) with present or previous history of decompensation (ascites, hepatic encephalopathy or bacterial infection). - Genotype 1b infection. - Inclusion after 4 weeks of resolution of hepatic encephalopathy, gastrointestinal bleeding or bacterial infection. - Viral load VHC?10000 UI/L Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 5

Exclusion criteria

Exclusion criteria: - Compensated cirrhosis. - Hepatocellular carcinoma. - Serum creatinine > 1.5 mg/dL. - Complications of cirrhosis associated with very poor outcome: refractory ascites, acute-on-chronic liver failure, hepatorenal syndrome, hyponatremia (serum sodium 10 mg/dL. - Severe extrahepatic diseases: cardiovascular, respiratory, cerebrovascular and poorly controlled diabetes that according to the investigator can difficult the antiviral therapy. - Platelets < 30 x 109 cells/L. - Neutrophil count < 0.5 x 109 cells/L. - Hemoglobin < 9 g/dL. - HIV infection. - Hepatitis B infection. - Active intake of toxic amounts of alcohol or recreational drugs. - Use of any medication listed in the following table

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the effects of treatment on liver function and systemic hemodynamics in patients with decompensated HCV-related cirrhosis;Secondary Objective: -To investigate the efficacy (SVR12) of Ombitasvir/Paritaprevir/ritonavir + Dasabuvir + Ribavirin in patients with Child B cirrhosis. -To evaluate the effect of treatment on the development of complications of cirrhosis. -To investigate the effect of treatment on systemic inflammation and endothelial function. -To evaluate the effect of treatment on quality of life. -To determine the safety of this antiviral combination in patients with decompensated cirrhosis. -To investigate the effect of SVR12 on changes of gut microbiota in patients with decompensated cirrhosis. -To assess the effects of SVR12 on cirrhosis regression;Primary end point(s): Improvement of liver function defined by a decrease in ?2 points in Child-Pugh score at 3 months after the end of antiviral therapy.;Timepoint(s) of evaluation of this end point: decrease in ?2 points in Child-Pugh score at 3 months after the end of antiviral therapy -	—

Measure

Time frame

Main Objective: To investigate the effects of treatment on liver function and systemic hemodynamics in patients with decompensated HCV-related cirrhosis;Secondary Objective: -To investigate the efficacy (SVR12) of Ombitasvir/Paritaprevir/ritonavir + Dasabuvir + Ribavirin in patients with Child B cirrhosis. -To evaluate the effect of treatment on the development of complications of cirrhosis. -To investigate the effect of treatment on systemic inflammation and endothelial function. -To evaluate the effect of treatment on quality of life. -To determine the safety of this antiviral combination in patients with decompensated cirrhosis. -To investigate the effect of SVR12 on changes of gut microbiota in patients with decompensated cirrhosis. -To assess the effects of SVR12 on cirrhosis regression;Primary end point(s): Improvement of liver function defined by a decrease in ?2 points in Child-Pugh score at 3 months after the end of antiviral therapy.;Timepoint(s) of evaluation of this end point: decrease in ?2 points in Child-Pugh score at 3 months after the end of antiviral therapy -

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Secondary

Measure	Time frame
Secondary end point(s): - Decrease in portal pressure 6 months after the end of treatment. - Decrease in the incidence of complications of cirrhosis during treatment and for a 6-months follow up period after treatment. A composite end point of complications of cirrhosis will be analyzed, including ascites, hepatic encephalopathy , bacterial infections and gastrointestinal bleeding. The development of the first of any of these five complications described above will define the occurrence of the end-point. - Changes in circulatory function assessed by plasma renin activity (PRA) and noradrenalin at the end of treatment and 6 months after the end of treatment with respect to baseline. - Changes in systemic inflammatory response and endothelial function assessed by cytokine, endotoxin and von Willebrand factor levels at the end of treatment and 6 months after the end of treatment with respect to baseline. - Improvement in quality of life evaluated by Short-form 36 (SF-36) and Chronic Liver Disease (CLDQ) questionnaires 6 months after the end of treatment with respect to baseline. - Changes in gut microbiota will be evaluated by analysis of fecal phylogenetic profiles before and after treatment. - Effects of SVR12 on cirrhosis regression will be assessed by transcriptome analysis of liver tissue samples before and 12w after treatment.;Timepoint(s) of evaluation of this end point: Virological end-points - SVR4 (sustained virological response 4 weeks the end of all study therapy). The subject has HCV RNA < 15 IU/ml 4 weeks after the end of all study therapy. - SVR12 (sustained virological response 12 weeks the end of all study therapy). The subject has HCV RNA < 15 IU/ml 12 weeks after the end of all study therapy	—

Measure

Time frame

Secondary end point(s): - Decrease in portal pressure 6 months after the end of treatment. - Decrease in the incidence of complications of cirrhosis during treatment and for a 6-months follow up period after treatment. A composite end point of complications of cirrhosis will be analyzed, including ascites, hepatic encephalopathy , bacterial infections and gastrointestinal bleeding. The development of the first of any of these five complications described above will define the occurrence of the end-point. - Changes in circulatory function assessed by plasma renin activity (PRA) and noradrenalin at the end of treatment and 6 months after the end of treatment with respect to baseline. - Changes in systemic inflammatory response and endothelial function assessed by cytokine, endotoxin and von Willebrand factor levels at the end of treatment and 6 months after the end of treatment with respect to baseline. - Improvement in quality of life evaluated by Short-form 36 (SF-36) and Chronic Liver Disease (CLDQ) questionnaires 6 months after the end of treatment with respect to baseline. - Changes in gut microbiota will be evaluated by analysis of fecal phylogenetic profiles before and after treatment. - Effects of SVR12 on cirrhosis regression will be assessed by transcriptome analysis of liver tissue samples before and 12w after treatment.;Timepoint(s) of evaluation of this end point: Virological end-points - SVR4 (sustained virological response 4 weeks the end of all study therapy). The subject has HCV RNA < 15 IU/ml 4 weeks after the end of all study therapy. - SVR12 (sustained virological response 12 weeks the end of all study therapy). The subject has HCV RNA < 15 IU/ml 12 weeks after the end of all study therapy

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Countries

Spain

Contacts

Public ContactAnna Cruceta

CTU -Farmacologia. Hospital clínic

acruceta@clinic.ub.es+349322754005380

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026