Back to resultsTreating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir (SD-CRF)
Primary Purpose
Hepatitis C, Chronic, Chronic Renal Failure
Status
Completed
Phase
Phase 4
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Sofosbuvir 400 mg and daclatasvir 60 mg
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring hepatitis C, renal failure, sofosbuvir, daclatasvir
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
Sites / Locations
- Shariati Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sovodak
Arm Description
Sofosbuvir 400 mg and daclatasvir 60 mg
Outcomes
Primary Outcome Measures
Sustained Viral Response (SVR12)
Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment
Secondary Outcome Measures
Safety as assessed by adverse drug events
Adverse drug events recorded by direct questioning
Full Information
NCT ID
NCT03063879
First Posted
February 21, 2017
Last Updated
September 27, 2019
Sponsor
Tehran University of Medical Sciences
Collaborators
Ahvaz Jundishapur University of Medical Sciences, Shiraz University of Medical Sciences, Hamadan University of Medical Science
1. Study Identification
Unique Protocol Identification Number
NCT03063879
Brief Title
Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir
Acronym
SD-CRF
Official Title
Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2017 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
February 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Ahvaz Jundishapur University of Medical Sciences, Shiraz University of Medical Sciences, Hamadan University of Medical Science
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic, Chronic Renal Failure
Keywords
hepatitis C, renal failure, sofosbuvir, daclatasvir
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sovodak
Arm Type
Experimental
Arm Description
Sofosbuvir 400 mg and daclatasvir 60 mg
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir 400 mg and daclatasvir 60 mg
Other Intervention Name(s)
Sovodak
Intervention Description
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
Primary Outcome Measure Information:
Title
Sustained Viral Response (SVR12)
Description
Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment
Time Frame
12 weeks after end of treatment
Secondary Outcome Measure Information:
Title
Safety as assessed by adverse drug events
Description
Adverse drug events recorded by direct questioning
Time Frame
From start of treatment to 12 weeks after end of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shahin Merat, MD
Organizational Affiliation
Tehran University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shariati Hospital
City
Tehran
ZIP/Postal Code
14117
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31994788
Citation
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.
Results Reference
derived
Learn more about this trial
Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir
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