Hepatitis CPhase 4SD1000NCT03200184
Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients
A Phase 4 study testing sofosbuvir and daclatasvir in people with Hepatitis C, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- sofosbuvir and daclatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,448 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2016to 1 Sep 2018
- 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 12 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
Who cannot join
- Heart rate < 50/min,
- Taking amiodarone
Trial locations and contacts
1 site in 1 country.
About this study
The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.
Read the detailed description
All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness > 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.
- Conditions
- Hepatitis C
- Being tested
- sofosbuvir and daclatasvir
- Keywords
- Hepatitis C, sofosbuvir, daclatasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sofosbuvir and daclatasvirDrug
Also called Sovodak
A fixed dose combination pill containing 400mg sofosbuvir and 60 mg daclatasvir given daily for 12 weeks. If a patient is cirrhotic, treatment duration would be 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Subjects will receive sofosbuvir and daclatasvir Receives: Drug: sofosbuvir and daclatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sustained viral response rate
Qualitative hepatitis C virus RNA polymerase chain reaction
Measured: 12 weeks after end of treatment
Secondary outcomes (1)
Adverse drug events
Questionnaire
Measured: weeks 2, 4, 8, 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2017
- Study start1 Sep 2016
- Primary completion1 Apr 2018
- Study completion1 Sep 2018
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 CStudies 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
- 1,448 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reza Malekzadeh, MD, Study chair, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200184
- Sponsor's protocol ID
- IR.TUMS.DDRI.REC.1396.30
- Acronym
- SD1000
- Status last verified
- May 2017
- First submitted
- 28 May 2017
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Merat S; SD1000 Research Team. SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial. Clin Infect Dis. 2020 May 6;70(10):2206-2212. doi: 10.1093/cid/ciz628.
PubMed 31504303
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sofosbuvir and Daclatasvir in Treating Hepatitis C, A Study on 1000 Patients
- ClinicalTrials.gov ID
- NCT03200184
- Acronym / sponsor ID
- SD1000 / IR.TUMS.DDRI.REC.1396.30
- Conditions
- Hepatitis C
- Keywords
- Hepatitis C, sofosbuvir, daclatasvir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,448 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Apr 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 27 Jun 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.
The fixed-dose combination of sofosbuvir and daclatasvir in a single pill is being used for the treatment of hepatitis C in Iran. In this study the efficacy of this combination is evaluated in 1000 patient with hepatitis C.
Detailed description
All cases of hepatitis C whether cirrhotic, post organ transplant, co-infected with HIV or hepatitis B, active drug abuse, on immune suppression and from all genotypes will be included. Patients will be treated by a single daily dose of a fixed-dose combination pill of 400mg sofosbuvir and 60 mg daclatasvir for 12 weeks. If a patient is cirrhotic, defined by liver stiffness > 12 kilopascal, either weight based ribavirin will be added or the treatment duration will be prolonged to 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: sofosbuvir and daclatasvirSubjects will receive sofosbuvir and daclatasvir |
Who may qualify
- Ages
- 12 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Positive qualitative hepatitis C virus RNA test on two occasions at least 6 months apart
Key exclusion criteria (2 listed)
- 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 and daclatasvirAlso: SovodakA fixed dose combination pill containing 400mg sofosbuvir and 60 mg daclatasvir given daily for 12 weeks. If a patient is cirrhotic, treatment duration would be 24 weeks. | Drug | Treatment |
Primary outcome
The sustained viral response rate
Time frame: 12 weeks after end of treatment
Qualitative hepatitis C virus RNA polymerase chain reaction
1 secondary outcome
Adverse drug events
Time frame: weeks 2, 4, 8, 12 and 24
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 15 Feb 2019.
- Derived from this study: PubMed 31504303Merat S; SD1000 Research Team. SD1000: High Sustained Viral Response Rate in 1361 Patients With Hepatitis C Genotypes 1, 2, 3, and 4 Using a Low-cost, Fixed-dose Combination Tablet of Generic Sofosbuvir and Daclatasvir: A Multicenter, Phase III Clinical Trial. Clin Infect Dis. 2020 May 6;70(10):2206-2212. doi: 10.1093/cid/ciz628.
- 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.
Reza Malekzadeh, MD study chair
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 and daclatasvir in people with Hepatitis C, 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 1 inclusion and 2 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 15 Feb 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?
The sustained viral response rate (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 NCT03200184, 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 15 Feb 2019.