Hepatitis C, ChronicPhase 4SD-CRFNCT03063879
Treating Hepatitis C in CRF Using Sofosbuvir and Daclatasvir
A Phase 4 study testing Sofosbuvir 400 mg and daclatasvir 60 mg in people with Hepatitis C, Chronic and Chronic Renal Failure, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Hepatitis C, Chronic, Chronic Renal Failure
- What is being tested?
- Sofosbuvir 400 mg and daclatasvir 60 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteIran
- Study dates
- 1 Apr 2017to 1 Feb 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
- Renal failure (eGFR < 30 cc/min) or under hemodialysis
Who cannot join
- Model for End-stage Liver Disease (MELD) score > 20,
- Child's C (CTP score > 12),
- Heart rate < 50/min,
- Taking amiodarone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.
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
- Being tested
- Sofosbuvir 400 mg and daclatasvir 60 mg
- Keywords
- hepatitis C, renal failure, sofosbuvir, daclatasvir
- Medical subject headings
- Hepatitis C, Chronic, Kidney Failure, Chronic, Hepatitis C, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir 400 mg and daclatasvir 60 mgDrug
Also called Sovodak
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
| Study group | Role | What they receive |
|---|---|---|
| Sovodak | Experimental | Sofosbuvir 400 mg and daclatasvir 60 mg Receives: Drug: Sofosbuvir 400 mg and daclatasvir 60 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Viral Response (SVR12)
Lack of detectable hepatitis C virus in blood 12 weeks after end of treatment
Measured: 12 weeks after end of treatment
Secondary outcomes (1)
Safety as assessed by adverse drug events
Adverse drug events recorded by direct questioning
Measured: From start of treatment to 12 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Apr 2017
- Primary completion1 Sep 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ahvaz Jundishapur University of Medical Sciences, Shiraz University of Medical Sciences, Hamadan University of Medical Science
- Responsible party
- Sponsor
- Investigators
- Shahin Merat, MD, Principal investigator, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063879
- Sponsor's protocol ID
- 96-04-37-37348
- Acronym
- SD-CRF
- Status last verified
- Feb 2018
- First submitted
- 21 Feb 2017
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Sofosbuvir and Daclatasvir in Treating Patients With Hepatitis C and Renal Failure.
- ClinicalTrials.gov ID
- NCT03063879
- Acronym / sponsor ID
- SD-CRF / 96-04-37-37348
- Conditions
- Hepatitis C, Chronic, Chronic Renal Failure
- Keywords
- hepatitis C, renal failure, sofosbuvir, daclatasvir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Ahvaz Jundishapur University of Medical Sciences, Shiraz University of Medical Sciences, Hamadan University of Medical Science
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sovodak | Experimental | Drug: Sofosbuvir 400 mg and daclatasvir 60 mgSofosbuvir 400 mg and daclatasvir 60 mg |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
- Renal failure (eGFR < 30 cc/min) or under hemodialysis
Key exclusion criteria (4 listed)
- Model for End-stage Liver Disease (MELD) score > 20,
- Child's C (CTP score > 12),
- Heart rate < 50/min,
- Taking amiodarone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sofosbuvir 400 mg and daclatasvir 60 mgAlso: SovodakDaily 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 | Drug | Sovodak |
Primary outcome
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
1 secondary outcome
Safety as assessed by adverse drug events
Time frame: From start of treatment to 12 weeks after end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Derived from this study: PubMed 31994788Poustchi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahin Merat, MD principal investigator
Tehran University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sofosbuvir 400 mg and daclatasvir 60 mg in people with Hepatitis C, Chronic and Chronic Renal Failure, run by Tehran University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Viral Response (SVR12) (time frame: 12 weeks after end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03063879, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.