Hepatitis CPhase 3NCT02646111
Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Protease-Inhibitors ("PI") Failures
A Phase 3 study testing 12 weeks without Ribavirin, 12 weeks with Ribavirin and 24 weeks with Ribavirin in people with Hepatitis C, run by Tel-Aviv Sourasky Medical Center.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors. 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?
- 12 weeks without Ribavirin, 12 weeks with Ribavirin and 24 weeks with Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 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
- Diagnosis of hepatitis C, genotype 1A or 1B.
- Documentation of PI failure of treatment at least 12 months prior to study entry.
- Patients with cirrhosis - (only patients with cirrhosis Child A with only 5 points).
Who cannot join
- Inability to stay in the study for 36 weeks.
- Diagnosis of cross-contamination by HIV or Hepatitis B virus.
- Renal disfunction (creatinine clearance <30 ml / min).
- Evidence of hepatic carcinoma.
- Another serious disease, which may interfere with the study.
- Pregnant / breast-feeding women.
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- Men with pregnant partners.
- Drug or alcohol abuse in the six months preceding the study.
- Chronic liver disease other than hepatitis C (such as Primary biliary cirrhosis, Primary sclerosing cholangitis, Autoimmune hepatitis).
- Current other treatment for HCV.
- Past PI Failure due to adverse events.
- Patients with cirrhosis Child B.
- Patients with cirrhosis, who were at child B and improved to child A after treatment.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure
The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors.
The "Triple therapy" of AbbVie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed PI treatment.
Read the detailed description
Patients with genotype 1 HCV, who underwent past triple therapy (Telaprevir, Boceprevir or Simeprevir with Pegylated interferon / Ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment.
At the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows:
- Group A - genotype 1b without cirrhosis - 12 weeks of treatment *
- Group B - genotype 1b with cirrhosis - 12 weeks of treatment
- Group C - genotype 1a without cirrhosis - 12 weeks of treatment
- Group D - genotype 1a with cirrhosis - 24 weeks of treatment (* Only this group will not get Ribavirin)
During the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: SF-36, and WPAI Hep C v2.0.
The follow up will also include physical assessments, side effects documentation, blood tests, abdominal Ultrasound and Fibroscan.
- Conditions
- Hepatitis C
- Being tested
- 12 weeks without Ribavirin, 12 weeks with Ribavirin, 24 weeks with Ribavirin
- Keywords
- "Hepatitis C Virus", "Triple Therapy", "PI Failure", "Genotype 1"
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12 weeks without RibavirinDrug
Also called Triple therapy
12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.
12 weeks with RibavirinDrug
Also called Triple therapy
12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
24 weeks with RibavirinDrug
Also called Triple therapy
24 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
| Study group | Role | What they receive |
|---|---|---|
| Genotype 1b without cirrhosis | Experimental | 12 weeks without Ribavirin Receives: Drug: 12 weeks without Ribavirin |
| Genotype 1b with cirrhosis | Experimental | 12 weeks with Ribavirin Receives: Drug: 12 weeks with Ribavirin |
| Genotype 1a without cirrhosis | Experimental | 12 weeks with Ribavirin Receives: Drug: 12 weeks with Ribavirin |
| Genotype 1a with cirrhosis | Experimental | 24 weeks with Ribavirin Receives: Drug: 24 weeks with Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
"SVR" (sustained virologic response) rates
Sustained virologic response
Measured: 12 weeks after end of treatment
Secondary outcomes (2)
"SF" (short-form)-36 health survey
psychometrically-based physical and mental health and a preference-based health utility index.
Measured: Day 1, weeks 4, 12, 24, 36.
WPAI Hep C v2.0 questionnaire
a scoring manual for work productivity and activity impairment assessment.
Measured: Day 1, weeks 4, 12, 24, 36.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2018 (estimated)
- Study completionJan 2019 (estimated)
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.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- Oren Shibolet, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646111
- Sponsor's protocol ID
- TASMC-15-OS-503-CTIL
- Status last verified
- Jan 2016
- First submitted
- 28 Dec 2015
- Last updated
- 5 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Deutsch L, Houri I, Ben-Ari Z, Shlomai A, Veitsman E, Cohen-Ezra O, Issachar A, Mor O, Gozlan Y, Bruck R, Menachem Y, Zelber-Sagi S, Katchman H, Shibolet O. Ombitasvir/paritaprevir/ritonavir & dasabuvir +/- ribavirin following protease inhibitors failure - a prospective multi-centre trial. BMC Infect Dis. 2020 Apr 3;20(1):264. doi: 10.1186/s12879-020-4921-3.
PubMed 32245397
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center Study to Evaluate Sustained Virologic Response With Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With and Without Ribavirin in Genotype 1 Chronic Hepatitis C Virus Infected Patients With Past PI Failure
- ClinicalTrials.gov ID
- NCT02646111
- Acronym / sponsor ID
- TASMC-15-OS-503-CTIL
- Conditions
- Hepatitis C
- Keywords
- "Hepatitis C Virus", "Triple Therapy", "PI Failure", "Genotype 1"
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2016
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 Jan 2016 (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.
The purpose of this study is to evaluate the efficacy and safety of triple therapy of AbbVie adults with chronic hepatitis C virus ("HCV"), who have not responded to prior treatment with protease inhibitors.
The "Triple therapy" of AbbVie attacks various sites of the viral genome, thus increasing the potential efficacy of the treatment, especially for patients who have failed PI treatment.
Detailed description
Patients with genotype 1 HCV, who underwent past triple therapy (Telaprevir, Boceprevir or Simeprevir with Pegylated interferon / Ribavirin) and are non-responders, partial responders or in relapse - will be screened in all research centers up to 30 days before the first treatment.
At the end of the initial assessment - the recruited participants will be allocated to different treatment groups in accordance with the hepatitis virus subtype 1a, 1b and presence of cirrhosis, as follows:
- Group A - genotype 1b without cirrhosis - 12 weeks of treatment *
- Group B - genotype 1b with cirrhosis - 12 weeks of treatment
- Group C - genotype 1a without cirrhosis - 12 weeks of treatment
- Group D - genotype 1a with cirrhosis - 24 weeks of treatment (* Only this group will not get Ribavirin)
During the treatment period, participants will be asked to describe the treatment's tolerability (in terms of side effects) using self-administered questionnaires: SF-36, and WPAI Hep C v2.0.
The follow up will also include physical assessments, side effects documentation, blood tests, abdominal Ultrasound and Fibroscan.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Genotype 1b without cirrhosis | Experimental | Drug: 12 weeks without Ribavirin12 weeks without Ribavirin |
| Genotype 1b with cirrhosis | Experimental | Drug: 12 weeks with Ribavirin12 weeks with Ribavirin |
| Genotype 1a without cirrhosis | Experimental | Drug: 12 weeks with Ribavirin12 weeks with Ribavirin |
| Genotype 1a with cirrhosis | Experimental | Drug: 24 weeks with Ribavirin24 weeks with Ribavirin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of hepatitis C, genotype 1A or 1B.
- Documentation of PI failure of treatment at least 12 months prior to study entry.
- Patients with cirrhosis - (only patients with cirrhosis Child A with only 5 points).
Key exclusion criteria (13 listed)
- Inability to stay in the study for 36 weeks.
- Diagnosis of cross-contamination by HIV or Hepatitis B virus.
- Renal disfunction (creatinine clearance <30 ml / min).
- Evidence of hepatic carcinoma.
- Another serious disease, which may interfere with the study.
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 |
|---|---|---|
| 12 weeks without RibavirinAlso: Triple therapy12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily. | Drug | Genotype 1b without cirrhosis |
| 12 weeks with RibavirinAlso: Triple therapy12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg. | Drug | Genotype 1a without cirrhosis, Genotype 1b with cirrhosis |
| 24 weeks with RibavirinAlso: Triple therapy24 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg. | Drug | Genotype 1a with cirrhosis |
Primary outcome
"SVR" (sustained virologic response) rates
Time frame: 12 weeks after end of treatment
Sustained virologic response
2 secondary outcomes
"SF" (short-form)-36 health survey
Time frame: Day 1, weeks 4, 12, 24, 36.
WPAI Hep C v2.0 questionnaire
Time frame: Day 1, weeks 4, 12, 24, 36.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2016.
- Derived from this study: PubMed 32245397Deutsch L, Houri I, Ben-Ari Z, Shlomai A, Veitsman E, Cohen-Ezra O, Issachar A, Mor O, Gozlan Y, Bruck R, Menachem Y, Zelber-Sagi S, Katchman H, Shibolet O. Ombitasvir/paritaprevir/ritonavir & dasabuvir +/- ribavirin following protease inhibitors failure - a prospective multi-centre trial. BMC Infect Dis. 2020 Apr 3;20(1):264. doi: 10.1186/s12879-020-4921-3.
- 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.
Oren Shibolet, MD principal investigator
Tel-Aviv Sourasky Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 12 weeks without Ribavirin, 12 weeks with Ribavirin and 24 weeks with Ribavirin in people with Hepatitis C, run by Tel-Aviv Sourasky Medical Center.
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 3 inclusion and 13 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 5 Jan 2016. 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 Oren Shibolet, MD (97236973984, orensh@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
"SVR" (sustained virologic response) rates (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 NCT02646111, 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 5 Jan 2016.