Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 (SL50)

April 27, 2018 updated by: Tehran University of Medical Sciences

Sustained Viral Response Rate in 50 Subjects With Cirrhosis Due to Hepatitis C, Genotype 1, Treated With 12 Weeks of Sofosbuvir, Ledipasvir and Ribavirin

The investigators will treat 50 patients with cirrhosis due to hepatitis C genotype 1, with sofosbuvir 400 mg daily, ledipasvir 90 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Cirrhosis due to Hepatitis C virus (HCV) presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of care. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and ledipasvir (LDV) 90 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks only for HCV genotype 1 patients. The current recommendation for cirrhotics (genotype 1) is SOF/LDV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/LDV/RBV the investigators decided to treat 50 HCV genotype 1 cirrhotics with this combination for 12 weeks. Patients with MELD score > 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

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

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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Positive qualitative hepatitis C RNA polymerase chain reaction assay on two occasions at least 6 months apart

Exclusion Criteria:

  • Renal failure [estimated glomerular filtration rate (eGFR) < 30 cc/min],
  • Model or End stage Liver Disease (MELD) score > 20,
  • Child's class C (score > 12),
  • Heart rate < 50/min,
  • Taking amiodarone

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Subjects will receive sofosbuvir, ledipasvir and ribavirin
Drug: Ribavirin
1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses
Other Names:
  • RBV
Drug: Sofosbuvir
400 mg, included in a combination pill with 90 mg ledipasvir
Other Names:
  • SOF
Drug: Ledipasvir
90 mg, included in a combination pill with 400 mg sofosbuvir
Other Names:
  • LDV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sustained viral response rate
Time Frame: week 24 (12 weeks after end of treatment)
Qualitative polymerase chain reaction assay for Hepatitis C RNA
week 24 (12 weeks after end of treatment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse drug events
Time Frame: week 2, 4, 8, 12, 24
Questionnaire
week 2, 4, 8, 12, 24

Collaborators and Investigators

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

Sponsor

Tehran University of Medical Sciences

Collaborators

Bakhtar Bioshimi Co

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)

September 1, 2016

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

March 7, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 10, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 94-04-37-31023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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