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Completed

NCT Number: NCT02705534

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

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.

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shariati Hospital

Tehran, 14117, Iran

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir

Drug

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

Other names: SOF

Ledipasvir

Drug

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

Other names: LDV

Ribavirin

Drug

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

Other names: RBV

Primary outcomes

  1. The sustained viral response rate

    Time frame: week 24 (12 weeks after end of treatment)

    Qualitative polymerase chain reaction assay for Hepatitis C RNA

Secondary outcomes

  1. Adverse drug events

    Time frame: week 2, 4, 8, 12, 24

    Questionnaire

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Bakhtar Bioshimi Co

Registry information

Official study title

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

Acronym: SL50

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 10, 2016
Registry last updated
Apr 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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