Hepatitis CPhase 3HepCC-2NCT03061032
Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients
A Phase 3 study testing Sofosbuvir/Ledipasvir 12W, Sofosbuvir/Ledipasvir plus Ribavirin 12W and Sofosbuvir/Ledipasvir 24W in people with Hepatitis C, run by Iran Hepatitis Network.
Trial summary
Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Sofosbuvir/Ledipasvir 12W, Sofosbuvir/Ledipasvir plus Ribavirin 12W and Sofosbuvir/Ledipasvir 24W
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Mar 2017to Jul 2019
- Phase
- Phase 3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic HCV infection
- >18 years old
Who cannot join
- HIV co-infected
- Liver transplanted
- Receiving drugs with suspected interactions
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection
Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.
- Conditions
- Hepatitis C
- Being tested
- Sofosbuvir/Ledipasvir 12W, Sofosbuvir/Ledipasvir plus Ribavirin 12W, Sofosbuvir/Ledipasvir 24W, Sofosbuvir/Ledipasvir plus Ribavirin 24W
- 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/Ledipasvir 12WDrug
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.
Sofosbuvir/Ledipasvir plus Ribavirin 12WDrug
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.
Sofosbuvir/Ledipasvir 24WDrug
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.
Sofosbuvir/Ledipasvir plus Ribavirin 24WDrug
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir/Ledipasvir for 12W | Experimental | Patients without cirrhosis and previous history of treatment will be treated with this regimen.
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks. Receives: Drug: Sofosbuvir/Ledipasvir 12W |
| Sofosbuvir/Ledipasvir+Ribavirin for 12W | Experimental | Patients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen.
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks. Receives: Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12W |
| Sofosbuvir/Ledipasvir for 24W | Experimental | Patients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen.
Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks. Receives: Drug: Sofosbuvir/Ledipasvir 24W |
| Sofosbuvir/Ledipasvir+Ribavirin for 24W | Experimental | Patients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks. Receives: Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24W |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response
Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection
Measured: 12 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study startMar 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iran Hepatitis Network
- Sponsor type
- University, hospital or other
- Collaborators
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases
- Responsible party
- Sponsor
- Investigators
- Seyed Moayed Alavian, MD, Study chair, Iran Hepatitis NetworkHeidar Sharafi, PhD, Study director, Iran Hepatitis NetworkBita Behnava, MD, Principal investigator, Iran Hepatitis NetworkMohammad Saeid Rezaee-Zavareh, MD, Principal investigator, Iran Hepatitis Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03061032
- Sponsor's protocol ID
- IHN10002
- Acronym
- HepCC-2
- Status last verified
- Feb 2017
- First submitted
- 13 Feb 2017
- Last updated
- 23 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Study of Efficacy and Safety of Generic Sofosbuvir/Ledipasvir±Ribavirin in Iranian Patients With Hepatitis C Virus Genotype 1 Infection
- ClinicalTrials.gov ID
- NCT03061032
- Acronym / sponsor ID
- HepCC-2 / IHN10002
- Conditions
- Hepatitis C
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Iran Hepatitis NetworkUniversity, hospital or other
- Collaborators
- Baqiyatallah Research Center for Gastroenterology and Liver Diseases
- Study start
- Mar 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 23 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.
Hepatitis C virus (HCV) infection with around 0.5% and 2.2% prevalence in Iran and world is one of the public health problems resulting in chronic liver disease, cirrhosis and hepatocellular carcinoma. All cases of chronic HCV infections are candidates of treatment to prevent advanced liver diseases. The previous Pegylated-interferon and Ribavirin therapy was not efficient in all cases and results in numerous number of side-effects. Introduction of direct acting antiviral agents (DAAs) such as Sofosbuvir and Ledipasvir make the eradication of HCV possible however these regimens are not affordable and available in developing countries. The generic DAAs are manufactured in many of these countries such as Iran to provide the treatment with reasonable price.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir/Ledipasvir for 12W | Experimental | Drug: Sofosbuvir/Ledipasvir 12WPatients without cirrhosis and previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks. |
| Sofosbuvir/Ledipasvir+Ribavirin for 12W | Experimental | Drug: Sofosbuvir/Ledipasvir plus Ribavirin 12WPatients with compensated cirrhosis and/or previous history of treatment will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks. |
| Sofosbuvir/Ledipasvir for 24W | Experimental | Drug: Sofosbuvir/Ledipasvir 24WPatients with compensated or decompensated cirrhosis and/or previous history of treatment and with contraindication of Ribavirin will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks. |
| Sofosbuvir/Ledipasvir+Ribavirin for 24W | Experimental | Drug: Sofosbuvir/Ledipasvir plus Ribavirin 24WPatients with decompensated cirrhosis will be treated with this regimen. Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Chronic HCV infection
- >18 years old
Key exclusion criteria (3 listed)
- HIV co-infected
- Liver transplanted
- Receiving drugs with suspected interactions
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/Ledipasvir 12WDaily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks. | Drug | Sofosbuvir/Ledipasvir for 12W |
| Sofosbuvir/Ledipasvir plus Ribavirin 12WDaily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks. | Drug | Sofosbuvir/Ledipasvir+Ribavirin for 12W |
| Sofosbuvir/Ledipasvir 24WDaily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks. | Drug | Sofosbuvir/Ledipasvir for 24W |
| Sofosbuvir/Ledipasvir plus Ribavirin 24WDaily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks. | Drug | Sofosbuvir/Ledipasvir+Ribavirin for 24W |
Primary outcome
Sustained Virologic Response
Time frame: 12 weeks after completion of treatment
Undetectable HCV RNA 12 weeks after completion of treatment with RT-PCR or TMA with a 15 IU/mL limit of detection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2017.
- Individual participant dataSharing planned: Undecided
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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.
Seyed Moayed Alavian, MD study chair
Iran Hepatitis Network
Heidar Sharafi, PhD study director
Iran Hepatitis Network
Bita Behnava, MD principal investigator
Iran Hepatitis Network
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofosbuvir/Ledipasvir 12W, Sofosbuvir/Ledipasvir plus Ribavirin 12W and Sofosbuvir/Ledipasvir 24W in people with Hepatitis C, run by Iran Hepatitis Network.
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 3 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: status not confirmed, as of the sponsor's last update on 23 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyed Moayed Alavian, MD (+989121073195, alavian@thc.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained Virologic Response (time frame: 12 weeks after completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Feb 2017.