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

May 13, 2020 updated by: Mohammed Abdel-Gabbar, Ph.D, Beni-Suef University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Beni-Suef, Egypt
        • Beni-Suef University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Cirrhotic Participants
The experienced participants(113 participants) who failed prior DAA treatments. They were allocated to cirrhotic (30 participants) and treated for 12 weeks.
Drug: SOF plus (OBV/PTV/r) plus RBV
They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.
Other Names:
  • Sovaldi is a trade name of sofosbuvir
  • Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease
  • Ombitasvir (ABT 267) is an NS5A inhibitor
ACTIVE_COMPARATOR: Non-cirrhotic Participants
The experienced non-cirrhotic participants(83 participants) who failed prior DAA treatments. They were treated for 12 weeks.
Drug: SOF plus (OBV/PTV/r) plus RBV
They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.
Other Names:
  • Sovaldi is a trade name of sofosbuvir
  • Paritaprevir (ABT-450) is inhibitor of the NS3-4A serine protease
  • Ombitasvir (ABT 267) is an NS5A inhibitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12) in Each Treatment Arm
Time Frame: 12 weeks after last dose
SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) level < 15 IU/ml 12 weeks after the last dose of drugs.
12 weeks after last dose
Number of Participants With Adverse Events in Each Treatment Arm
Time Frame: Screening up to 12 weeks after last dose]
An adverse event (AE) is defined as any untoward medical occurrence in a participant clinical investigation after administering a pharmaceutical drugs Serious adverse event (SAE) is an event that results in death, life-threatening, requires hospitalization, or significant disability/incapacity
Screening up to 12 weeks after last dose]

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Viral relapse
Time Frame: Up to 12 weeks after last dose
Viral relapse was HCV RNA level undetectable at End of Treatment (EOT) (≤ 15 IU/ml), but detectable HCV RNA ( > 15 IU/ml) levels 12 weeks after planned EOT.
Up to 12 weeks after last dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ACTUAL)

October 31, 2017

Study Completion (ACTUAL)

October 31, 2017

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 13, 2020

First Posted (ACTUAL)

May 18, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 18, 2020

Last Update Submitted That Met QC Criteria

May 13, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Qu-RBV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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