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Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1

NCT02705534 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2018-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Hepatitis C
  • Cirrhosis

Interventions

DRUG

Sofosbuvir

400 mg, included in a combination pill with 90 mg ledipasvir

DRUG

Ledipasvir

90 mg, included in a combination pill with 400 mg sofosbuvir

DRUG

Ribavirin

1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses

Sponsors & Collaborators

  • Bakhtar Bioshimi Co

    collaborator UNKNOWN

  • Tehran University of Medical Sciences

    lead OTHER

Principal Investigators

  • Reza Malekzadeh, M.D. · Tehran University of Medical Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2017-09-30
Completion
2017-10-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02705534 on ClinicalTrials.gov