CClinicalTrials.gg
Sign In
CompletedNCT03063879SD-CRFUpdated Sep 30, 2019

Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir

A Phase 4 interventional study of Sofosbuvir 400 mg and daclatasvir 60 mg in Hepatitis C, Chronic and Chronic Renal Failure, sponsored by Tehran University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2019-09-30.

Sponsored by Tehran University of Medical Sciences · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hepatitis C, Chronic
  • Chronic Renal Failure

Keywords

  • hepatitis C
  • renal failure
  • sofosbuvir
  • daclatasvir
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 95 is close to the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Tehran University of Medical Sciences is the lead sponsor of 227 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Model for End-stage Liver Disease (MELD) score > 20,
  • Child's C (CTP score > 12),
  • Heart rate \< 50/min,
  • Taking amiodarone
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • Experimental
    Sovodak

    Sofosbuvir 400 mg and daclatasvir 60 mg

    Drug: Sofosbuvir 400 mg and daclatasvir 60 mg

Interventions

  • DrugSofosbuvir 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

    Also known as: Sovodak

06

What researchers measure

Primary outcomes

  1. Sustained Viral Response (SVR12)

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

    Time frame: 12 weeks after end of treatment

Secondary outcomes

  1. Safety as assessed by adverse drug events

    Adverse drug events recorded by direct questioning

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

07

Study locations

1 site
  • Shariati Hospital
    Tehran, 14117, Iran, Islamic Republic of
08

References and documents

Publications

  • 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. PubMed 31994788 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03063879
Lead sponsor
Tehran University of Medical Sciences
Collaborators
Ahvaz Jundishapur University of Medical Sciences, Shiraz University of Medical Sciences, Hamadan University of Medical Science
Responsible party
Sponsor
First posted
Feb 24, 2017
Start date
Apr 1, 2017
Primary completion
Sep 1, 2018
Completion
Feb 1, 2019
Last update
Sep 30, 2019

Study contacts

Shahin Merat, MD
principal investigator · Tehran University of Medical Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hepatitis A→

Other studies from this sponsor

Tehran University of Medical Sciences

Start the discussion