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Completed

NCT Number: NCT03063879

Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

Sofosbuvir is the base of most treatment regimens for hepatitis C. In patients with renal failure the blood level of one of its metabolites (GS-331007) rises up to 20 folds. Although no particular adverse event has been linked to this metabolite sofosbuvir is not recommended for patients with renal failure mainly because of lack of data. Nevertheless there are anecdotal reports and small studies proving the safety of sofosbuvir in renal failure. This study addresses this lack of information by evaluating the safety and efficacy of sofosbuvir and daclatasvir in treating hepatitis C in 100 patients with renal failure.

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Chronic Disease Chronic Renal Failure Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Infections Kidney Diseases Kidney Failure, Chronic Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Virus Diseases

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shariati Hospital

Tehran, 14117, Iran

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
  • Renal failure (eGFR < 30 cc/min) or under hemodialysis

Exclusion criteria

  • Model for End-stage Liver Disease (MELD) score > 20,
  • Child's C (CTP score > 12),
  • Heart rate < 50/min,
  • Taking amiodarone

Treatment and study plan

Sofosbuvir 400 mg and daclatasvir 60 mg

Drug

Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness < 12 KPa) or 24 weeks if cirrhotic

Other names: Sovodak

Primary outcomes

  1. Sustained Viral Response (SVR12)

    Time frame: 12 weeks after end of treatment

    Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment

Secondary outcomes

  1. Safety as assessed by adverse drug events

    Time frame: From start of treatment to 12 weeks after end of treatment

    Adverse drug events recorded by direct questioning

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Collaborators

  • Ahvaz Jundishapur University of Medical Sciences
  • Hamadan University of Medical Science
  • Shiraz University of Medical Sciences

Registry information

Official study title

Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.

Acronym: SD-CRF

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Feb 24, 2017
Registry last updated
Sep 30, 2019

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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