HCV CoinfectionPhase 4NCT03050905
Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus Genotype 2K/1B
A Phase 4 study testing VEKIRAX and EXVIERA in people with HCV Coinfection, run by HaEmek Medical Center, Israel at 1 site in Israel.
Trial summary
HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HCV Coinfection
- What is being tested?
- VEKIRAX and EXVIERA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteIsrael
- Study dates
- 22 Jun 2017to 28 Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Male and female
- HCV Genotype 2K/1B (P/R experienced or naïve; non-cirrhotic/ Comp. cirrhotic CP-A 5)
- Capable to provide informed consent
Who cannot join
- Could not remain in the study for 36 weeks
- Co-infected with human immunodeficiency virus (HIV) or HBV
- Severe renal impairment (calculated creatinine clearance <30 mL/min )
- Evidence of hepatocellular carcinoma (HCC)
- Severe concurrent disease
- Pregnant, lactating, expecting to conceive or donate eggs or male participant with pregnant female partner
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- DAA treatment experienced
- History of drug or alcohol abuse within 6 months prior enrolment - positive result of a urine drug screen at the screening visit and a positive result on the alcohol consumption questioner.
- Evidence or history of chronic liver disease not caused by HCV Participants currently enrolled in an HCV-related research protocol OR currently receiving HCV treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus (HCV) Infection Genotype 2K/1B- NINJA Study
HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution.
Since different HCV genotypes react differently on available antiviral therapies, the correct identification of HCV genotype serves as a marker of responsiveness and an indicator for duration of treatment.
Read more
The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002.
A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these findings, the number of patients with 2k/1b may be underestimated.
AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3 DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV proteins essential for viral replication. The high efficacy of the 3D regimen was proven in registration clinical trials and RW for 1b population.
3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective
- Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b.
Study Design:
.The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of treatment and extra 24 weeks of follow up. Scheduled visits will include: physician assessment and blood tests including HCV resistance mutations.
Read the detailed description
Study Procedures:
Initial screening period:
HCV GT2K/1B -infected subjects who will be meeting eligibility criteria, will provide written informed consent, perform baseline RAS testing and will be enrolled to the study.
Baseline period:
On day 0, all patients will be assessed by a general physical examination, blood and urine tests including HCV resistance mutations (elaborated in the budget file), Fibroscan or SHEAR WAVE Elastography and abdominal ultrasound. After the initial assessment all included will be allocated for treatment.
Study configuration:
The study will include 1 group of patients infected GT 2k1b. Patients will be treated according to label recommendation for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Scheduled visits will take place in 0, 4, 12 and 24 weeks for all patients.
All visits will include: physician assessment and blood tests as elaborated in the Study Flowchart. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants.
- Conditions
- HCV Coinfection
- Being tested
- VEKIRAX, EXVIERA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VEKIRAXDrug
Also called Ombitasvir+Paritaprevir+Ritonavir
Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (Viekirax).
Study Regimen: ombitasvir+paritaprevir+ritonavir (25+150+100mg once daily)
EXVIERADrug
Also called Dasabuvir
Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Dasabuvir (Exviera).
Study Regimen: dasabuvir (250 mg twice daily)
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | The study will include 1 group. Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (VEKIRAX) and Dasabuvir (EXVIERA). Receives: Drug: VEKIRAX; Drug: EXVIERA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients achieving SVR12 (single last HCV RNA <12 IU/mL 12 weeks after the last actual dose of the ABBVIE regimen)
Measured: 12 weeks post treatment
Secondary outcomes (4)
Safety: absolute and relative numbers of discontinuations, AE and SAEs (Number of Participants With Adverse Events That Are Related to Treatment).
Measured: 36 weeks
Resistance Associated Substitute (RAS): The percentage of patients with the presence of RAS's- at baseline and at post-treatment weak 12.
Measured: 12 weeks post treatment
Time of virologic failure using population sequencing; SVR12 rate
Measured: 36 weeks
Time of virologic failure using population sequencing; presence of BL RAS's.
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 posted13 Feb 2017
- Study start22 Jun 2017
- Primary completion16 Nov 2017
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV CoinfectionStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050905
- Sponsor's protocol ID
- NINJA Study - 11227
- Status last verified
- Aug 2019
- First submitted
- 11 Dec 2016
- Last updated
- 9 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus (HCV) Infection Genotype 2K/1B- NINJA Study
- ClinicalTrials.gov ID
- NCT03050905
- Acronym / sponsor ID
- NINJA Study - 11227
- Conditions
- HCV Coinfection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 16 Nov 2017 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 13 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.
HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution.
Since different HCV genotypes react differently on available antiviral therapies, the correct identification of HCV genotype serves as a marker of responsiveness and an indicator for duration of treatment.
The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002.
A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these findings, the number of patients with 2k/1b may be underestimated.
AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3 DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV proteins essential for viral replication. The high efficacy of the 3D regimen was proven in registration clinical trials and RW for 1b population.
3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective
- Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b.
Study Design:
.The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of treatment and extra 24 weeks of follow up. Scheduled visits will include: physician assessment and blood tests including HCV resistance mutations.
Detailed description
Study Procedures:
Initial screening period:
HCV GT2K/1B -infected subjects who will be meeting eligibility criteria, will provide written informed consent, perform baseline RAS testing and will be enrolled to the study.
Baseline period:
On day 0, all patients will be assessed by a general physical examination, blood and urine tests including HCV resistance mutations (elaborated in the budget file), Fibroscan or SHEAR WAVE Elastography and abdominal ultrasound. After the initial assessment all included will be allocated for treatment.
Study configuration:
The study will include 1 group of patients infected GT 2k1b. Patients will be treated according to label recommendation for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Scheduled visits will take place in 0, 4, 12 and 24 weeks for all patients.
All visits will include: physician assessment and blood tests as elaborated in the Study Flowchart. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants.
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: VEKIRAX, Drug: EXVIERAThe study will include 1 group. Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (VEKIRAX) and Dasabuvir (EXVIERA). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- Male and female
- HCV Genotype 2K/1B (P/R experienced or naïve; non-cirrhotic/ Comp. cirrhotic CP-A 5)
- Capable to provide informed consent
Key exclusion criteria (9 listed)
- Could not remain in the study for 36 weeks
- Co-infected with human immunodeficiency virus (HIV) or HBV
- Severe renal impairment (calculated creatinine clearance <30 mL/min )
- Evidence of hepatocellular carcinoma (HCC)
- Severe concurrent disease
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 |
|---|---|---|
| VEKIRAXAlso: Ombitasvir+Paritaprevir+RitonavirPatients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (Viekirax). Study Regimen: ombitasvir+paritaprevir+ritonavir (25+150+100mg once daily) | Drug | Treatment |
| EXVIERAAlso: DasabuvirPatients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Dasabuvir (Exviera). Study Regimen: dasabuvir (250 mg twice daily) | Drug | Treatment |
Primary outcome
The percentage of patients achieving SVR12 (single last HCV RNA <12 IU/mL 12 weeks after the last actual dose of the ABBVIE regimen)
Time frame: 12 weeks post treatment
4 secondary outcomes
Safety: absolute and relative numbers of discontinuations, AE and SAEs (Number of Participants With Adverse Events That Are Related to Treatment).
Time frame: 36 weeks
Resistance Associated Substitute (RAS): The percentage of patients with the presence of RAS's- at baseline and at post-treatment weak 12.
Time frame: 12 weeks post treatment
Time of virologic failure using population sequencing; SVR12 rate
Time frame: 36 weeks
Time of virologic failure using population sequencing; presence of BL RAS's.
Time frame: 36 weeks
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 9 Aug 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 VEKIRAX and EXVIERA in people with HCV Coinfection, run by HaEmek Medical Center, Israel at 1 site in Israel.
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 4 inclusion and 9 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 9 Aug 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 Israel. 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 percentage of patients achieving SVR12 (single last HCV RNA <12 IU/mL 12 weeks after the last actual dose of the ABBVIE regimen) (time frame: 12 weeks post 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 9 Aug 2019.