Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

NCT ID: NCT03063879

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-01
• Study Completion Date: 2019-02-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sovodak

Sofosbuvir 400 mg and daclatasvir 60 mg

Group Type: EXPERIMENTAL

Sofosbuvir 400 mg and daclatasvir 60 mg

Intervention Type: 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

Interventions

Sofosbuvir 400 mg and daclatasvir 60 mg

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

Intervention Type: DRUG

Other Intervention Names

Sovodak

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ahvaz Jundishapur University of Medical Sciences

OTHER

Sponsor Role: collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role: collaborator

Hamadan University of Medical Science

OTHER

Sponsor Role: collaborator

Tehran University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shahin Merat, MD

Role: PRINCIPAL_INVESTIGATOR

Tehran University of Medical Sciences

Locations

Shariati Hospital

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: DERIVED

PMID: 31994788 (View on PubMed)

Other Identifiers

96-04-37-37348

Identifier Type: -

Identifier Source: org_study_id