HCV Related CirrhosisNCT02464631
To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis
A study testing Sofosbuvir + Ribavirin 1, Sofosbuvir + Ribavirin 2 and Sofosbuvir + Ribavirin 3 in people with HCV Related Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary Sciences hospital will be included and those patients meeting the entry criteria received treatment with 400 mg of Sofosbuvir… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HCV Related Cirrhosis
- What is being tested?
- Sofosbuvir + Ribavirin 1, Sofosbuvir + Ribavirin 2 and Sofosbuvir + Ribavirin 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female ≥ 18 yrs
- Baseline HCV RNA > 1000 IU/ml
- Cirrhosis with current or prior decompensation
- HCV (Hepatitis C Infection) Genotype 3
- Treatment naïve or treatment experienced
Who cannot join
- HIV or HBV (Hepatitis B Virus) co-infection
- Recent Variceal bleed
- Pregnancy
- Haemolytic anaemia
- Platelet counts <20,000/ml
- Advanced HCC (Hepatocellular Carcinoma)
Show all 10Show fewer
- Renal dysfunction, GFR (glomerular filtration rate) < 30 ml/min
- Haemoglobin < 10 g/dl
- MELD (Model for End Stage Liver Disease) >25, CTP (Child-Turcotte-Pugh score) >12
- Post organ transplant
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study
In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary Sciences hospital will be included and those patients meeting the entry criteria received treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin administered orally twice daily, with doses determined according to body weight(600 mg daily in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg, and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration, patients would be randomized in either of the 3 treatment groups -
- Group 1 - Sofosbuvir + Ribavirin x 24 weeks
- Group 2 - Sofosbuvir + Ribavirin x 36 weeks
- Group 3 - Sofosbuvir + Ribavirin x 48 weeks
- Conditions
- HCV Related Cirrhosis
- Being tested
- Sofosbuvir + Ribavirin 1, Sofosbuvir + Ribavirin 2, Sofosbuvir + Ribavirin 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir + Ribavirin 1Drug
Sofosbuvir + Ribavirin 2Drug
Sofosbuvir + Ribavirin 3Drug
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir + Ribavirin 1 | Active comparator | Sofosbuvir + Ribavirin x 24 weeks Receives: Drug: Sofosbuvir + Ribavirin 1 |
| Sofosbuvir + Ribavirin 2 | Experimental | Sofosbuvir + Ribavirin x 36 weeks Receives: Drug: Sofosbuvir + Ribavirin 2 |
| Sofosbuvir + Ribavirin 3 | Experimental | Sofosbuvir + Ribavirin x 48 weeks Receives: Drug: Sofosbuvir + Ribavirin 3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
Measured: 48 weeks
Secondary outcomes (7)
The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.
Measured: 3 years
Mortality at 6 months post therapy in all the 3 groups.
Measured: 48 weeks
Improvement in the liver function as determined by CTP (Child-Turcotte-Pugh score), MELD (Model for End Stage liver Disease)more than 2 points at 6 months and 1 year.
Measured: 48 weeks
Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.
Measured: 48 weeks
Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.
Measured: 48 weeks
SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)
Measured: 24 weeks
SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV Related CirrhosisStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ankur Jindal, DM, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02464631
- Sponsor's protocol ID
- ILBS-HCV-001
- Status last verified
- Jan 2016
- First submitted
- 22 May 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Efficacy of Sofosbuvir and Ribavirin in Patients With HCV (Genotype 3) Related Decompensated Cirrhosis" - A Randomized Open- Label Study
- ClinicalTrials.gov ID
- NCT02464631
- Acronym / sponsor ID
- ILBS-HCV-001
- Conditions
- HCV Related Cirrhosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 8 Jun 2015 (estimated)
- 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.
In this prospective randomized trial, A Minimum of 300 consecutive patients of decompensated HCV (Hepatitis C Virus) related cirrhosis, presenting to the Institute of Liver and Biliary Sciences hospital will be included and those patients meeting the entry criteria received treatment with 400 mg of Sofosbuvir, administered orally once daily, and Ribavirin administered orally twice daily, with doses determined according to body weight(600 mg daily in patients with a body weight of ≤60 kg,800 mg daily in patients weighing >60 and ≤80 kg, and1000 mg daily in patients with a body weight of >80 kg). Based on the treatment duration, patients would be randomized in either of the 3 treatment groups -
- Group 1 - Sofosbuvir + Ribavirin x 24 weeks
- Group 2 - Sofosbuvir + Ribavirin x 36 weeks
- Group 3 - Sofosbuvir + Ribavirin x 48 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir + Ribavirin 1 | Active comparator | Drug: Sofosbuvir + Ribavirin 1Sofosbuvir + Ribavirin x 24 weeks |
| Sofosbuvir + Ribavirin 2 | Experimental | Drug: Sofosbuvir + Ribavirin 2Sofosbuvir + Ribavirin x 36 weeks |
| Sofosbuvir + Ribavirin 3 | Experimental | Drug: Sofosbuvir + Ribavirin 3Sofosbuvir + Ribavirin x 48 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or Female ≥ 18 yrs
- Baseline HCV RNA > 1000 IU/ml
- Cirrhosis with current or prior decompensation
- HCV (Hepatitis C Infection) Genotype 3
- Treatment naïve or treatment experienced
Key exclusion criteria (10 listed)
- HIV or HBV (Hepatitis B Virus) co-infection
- Recent Variceal bleed
- Pregnancy
- Haemolytic anaemia
- Platelet counts <20,000/ml
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 + Ribavirin 1 | Drug | Sofosbuvir + Ribavirin 1 |
| Sofosbuvir + Ribavirin 2 | Drug | Sofosbuvir + Ribavirin 2 |
| Sofosbuvir + Ribavirin 3 | Drug | Sofosbuvir + Ribavirin 3 |
Primary outcome
The Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification)
Time frame: 48 weeks
7 secondary outcomes
The secondary endpoint is any AE (Adverse Event) leading to permanent discontinuation of study drugs.
Time frame: 3 years
Mortality at 6 months post therapy in all the 3 groups.
Time frame: 48 weeks
Improvement in the liver function as determined by CTP (Child-Turcotte-Pugh score), MELD (Model for End Stage liver Disease)more than 2 points at 6 months and 1 year.
Time frame: 48 weeks
Number of new cases of Hepatocellular Carcinoma at end of therapy and at 6 months post therapy in all the 3 groups.
Time frame: 48 weeks
Reduction in HVPG >20% to baseline after 1 year in all the 3 groups.
Time frame: 48 weeks
SVR 4 defined as HCV RNA <LLOQ (lower limit of quantification)
Time frame: 24 weeks
SVR 12 defined as HCV RNA <LLOQ (lower limit of quantification)
Time frame: 36 weeks
Results and safety
The study was stopped early (reason given: In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
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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.
Ankur Jindal, DM principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sofosbuvir + Ribavirin 1, Sofosbuvir + Ribavirin 2 and Sofosbuvir + Ribavirin 3 in people with HCV Related Cirrhosis, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 19 Jan 2017. 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 India. 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.
Are results available for this study?
The study was stopped early (reason given: In view of recent approval of NS5A inhibitors for treatment of hepatitis C such as Declatasvir and Ledipasvir which have proven better efficacy in the HCV cure). Results are not available in the source record.
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 Primary efficacy end point is SVR 24 defined as HCV RNA <LLOQ (lower limit of quantification) (time frame: 48 weeks). 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 19 Jan 2017.