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Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir and Ribavirin for Hepatitis C Virus Genotype 4 Patients

Retreatment Efficacy of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir + Ribavirin for Hepatitis C Virus Genotype 4 Patients

NCT04391985•Beni-Suef University

View on ClinicalTrials.gov

Summary

enrolled participants were treated orally with SOF plus a fixed dose combination of OBV/PTV/r plus RBV.

Detailed Description

Enrolled participants were treated orally with SOF plus a fixed dose combination of Sofosbuvir/Ombitasvir/Paritaprevir/ Ritonavir plus Ribavirin (OBV/PTV/r plus RBV), which was administered orally based on the participants' tolerability. The primary end point was a sustained virological response (HCV RNA level \< 15 IU/ mL), observed 12 weeks after the end of the treatment (SVR12).

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•The experienced participants who were treated previously with (SOF/DCV) , (SOF/SMV), (SOF/RBV), or (SOF/pegINF/RBV).
•The presence of compensated liver cirrhosis was documented by ultrasonographic examination, liver biopsy, results of Fibroscan or FIB-4 score, and laboratory markers, like FIB-4 \> 3.25 (advanced fibrosis or cirrhosis), albumin \< 3.5, total bilirubin \> 1.2, and also confirmed by clinical characteristics such as lower limb edema, splenomegaly, esophageal varices.

Exclusion Criteria

•liver disease of non-HCV GT4 etiology, coinfection with hepatitis B or HIV
•poorly controlled diabetes (HbA1C \> 8)
•participants, hepatocellular carcinoma, a history of extrahepatic malignancy in the 5 years prior to the study
•renal failure
•evidence of hepatic decompensation
•blood picture abnormalities such as anemia (hemoglobin concentration of \< 10 g/dL)
•thrombocytopenia (platelets count \< 50,000 cells/mm3).
•major severe illness such as congestive heart failure and respiratory failure.

Locations (1)

Beni-Suef University

Banī Suwayf, Egypt

Key Dates

Start Date

March 1, 2017

Primary Completion Date

October 31, 2017

Completion Date

October 31, 2017

Last Updated

May 18, 2020

Enrollment

113

ACTUAL participants

Conditions

Chronic Hepatitis C Virus Infection

Interventions

SOF plus (OBV/PTV/r) plus RBV

DRUG

Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

NCT04385407

Chronic Hepatitis C Virus Infection

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COMPLETEDPHASE2

Study of CTS-1027 in Hepatitis C Patients

NCT00570336

Chronic Hepatitis C Virus Infection

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COMPLETED

sgp130 in Chronic Human Liver Disease

NCT00770198

Alcoholic Liver Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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