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

NCT02705534 | Completed Phase 3

• 1 other identifier: 94-04-37-31023
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hepatitis C; Cirrhosis; Sofosbuvir; Ledipasvir; Ribavirin

Outcome Measures

Primary Outcomes (1)

• The sustained viral response rate

  Qualitative polymerase chain reaction assay for Hepatitis C RNA

  week 24 (12 weeks after end of treatment)

Secondary Outcomes (1)

• Adverse drug events

  week 2, 4, 8, 12, 24

Study Arms (1)

Treatment

EXPERIMENTAL

Subjects will receive sofosbuvir, ledipasvir and ribavirin

Drug: Sofosbuvir; Drug: Ledipasvir; Drug: Ribavirin

Interventions

Sofosbuvir DRUG

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

Also known as: SOF

Treatment

Ledipasvir DRUG

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

Also known as: LDV

Treatment

Ribavirin DRUG

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

Also known as: RBV

Treatment

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Bakhtar Bioshimi Co: collaborator

Study Sites (1)

Shariati Hospital

Tehran, 14117, Iran

Location

MeSH Terms

Conditions

Hepatitis C; Fibrosis

Interventions

Sofosbuvir; ledipasvir; Ribavirin

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides

Study Officials

• Reza Malekzadeh, M.D.

  Tehran University of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2016
• First Posted: March 10, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: April 30, 2018

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)