Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

NCT03063879 | Completed Phase 4

• 1 other identifier: 96-04-37-37348
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatitis C, Chronic; Chronic Renal Failure

Keywords

hepatitis C; renal failure; sofosbuvir; daclatasvir

Outcome Measures

Primary Outcomes (1)

• Sustained Viral Response (SVR12)

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

  12 weeks after end of treatment

Secondary Outcomes (1)

• Safety as assessed by adverse drug events

  From start of treatment to 12 weeks after end of treatment

Study Arms (1)

Sovodak

EXPERIMENTAL

Sofosbuvir 400 mg and daclatasvir 60 mg

Drug: Sofosbuvir 400 mg and daclatasvir 60 mg

Interventions

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

Also known as: Sovodak

Sovodak

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead
• Ahvaz Jundishapur University of Medical Sciences: collaborator
• Shiraz University of Medical Sciences: collaborator
• Hamadan University of Medical Science: collaborator

Study Sites (1)

Shariati Hospital

Tehran, 14117, Iran

Location

Related Publications (1)

• Poustchi H, Majd Jabbari S, Merat S, Sharifi AH, Shayesteh AA, Shayesteh E, Minakari M, Fattahi MR, Moini M, Roozbeh F, Mansour-Ghanaei F, Afshar B, Mokhtare M, Amiriani T, Sofian M, Somi MH, Agah S, Maleki I, Latifnia M, Fattahi Abdizadeh M, Hormati A, Khoshnia M, Sohrabi M, Malekzadeh Z, Merat D, Malekzadeh R. The combination of sofosbuvir and daclatasvir is effective and safe in treating patients with hepatitis C and severe renal impairment. J Gastroenterol Hepatol. 2020 Sep;35(9):1590-1594. doi: 10.1111/jgh.14994. Epub 2020 Feb 5.

  PMID: 31994788 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Kidney Failure, Chronic; Hepatitis C; Renal Insufficiency

Interventions

Sofosbuvir; daclatasvir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Shahin Merat, MD

  Tehran University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2017
• First Posted: February 24, 2017
• Study Start: April 1, 2017
• Primary Completion: September 1, 2018
• Study Completion: February 1, 2019
• Last Updated: September 30, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)