Hepatitis C, ChronicPhase 2NCT02765490
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
A Phase 2 study testing AL-335, Odalasvir and Simeprevir in people with Hepatitis C, Chronic, run by Janssen Research & Development, LLC at 28 sites in 6 countries.
Trial summary
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- AL-335, Odalasvir and Simeprevir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 365 participants
- Where
- 28 sitesin 6 countries
- Study dates
- 9 Nov 2016to 16 Nov 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
- Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
- Absence of cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or sexually active male
Who cannot join
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
- Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or a nursing female
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
Belgium6 sites
Study site
Antwerp
Study site
Brussels
Study site
Edegem
Study site
Ghent
Study site
Kortrijik
Study site
Leuven
Canada6 sites
Study site
Monteral, Quebec
Study site
Montreal, Quebec
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Vaughan, Ontario
Study site
Victoria, British Columbia
Germany5 sites
Study site
Berlin
Study site
Essen
Study site
Frankfurt
Study site
Hamburg
Study site
Leipzig
Poland5 sites
Study site
Lodz
Study site
Lublin
Study site
Mysłowice
Study site
Warsaw
Study site
Wroclaw
Spain5 sites
Study site
Barcelona
Study site
Madrid
Study site
Málaga
Study site
Seville
Study site
Valencia
About this study
Official title: A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
Read the detailed description
This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.
- Conditions
- Hepatitis C, Chronic
- Being tested
- AL-335, Odalasvir, Simeprevir
- Keywords
- Hepatitis C, Chronic, AL-335, Odalasvir, Simeprevir, ODV, SMV, ACH-3102, ACH-0143102, TMC435
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL-335Drug
AL-335 800 mg (2*400) tablet will be administered once daily.
OdalasvirDrug
Odalasvir 25 mg tablet will be administered once daily.
SimeprevirDrug
Simeprevir 75 mg capsule will be administered once daily.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks. Receives: Drug: AL-335; Drug: Odalasvir; Drug: Simeprevir |
| Group B | Experimental | AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks. Receives: Drug: AL-335; Drug: Odalasvir; Drug: Simeprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.
Measured: Week 12 (Follow-Up Phase)
Secondary outcomes (5)
Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
The SVR24 was defined as HCV RNA <LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT).
Measured: Week 24 (Follow-Up Phase)
Number of Participants With Viral Relapse
Viral Relapse: Participants who did not achieve SVR12, with HCV RNA <LLOQ at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.
Measured: End of Treatment up to Week 24 (Follow up phase)
Number of Participants With Late Viral Relapse
Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up.
Measured: Up to Week 24 (Follow-up Phase)
Percentage of Participants With On-treatment Failure
On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT).
Measured: EOT up to Week 12 (Follow up Phase)
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).
Measured: Week 4 (Follow-Up Phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study start9 Nov 2016
- Primary completion9 Aug 2017
- Study completion16 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765490
- Sponsor's protocol ID
- CR108070
- Other IDs
- 64294178HPC2001, 2015-004200-38, 2015
- Status last verified
- Nov 2019
- First submitted
- 5 May 2016
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis
- ClinicalTrials.gov ID
- NCT02765490
- Acronym / sponsor ID
- CR108070
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, Chronic, AL-335, Odalasvir, Simeprevir, ODV, SMV, ACH-3102, ACH-0143102
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 365 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 9 Aug 2017 (actual)
- Study completion
- 16 Nov 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 22 Jan 2019
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 (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.
Detailed description
This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: AL-335, Drug: Odalasvir, Drug: SimeprevirAL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks. |
| Group B | Experimental | Drug: AL-335, Drug: Odalasvir, Drug: SimeprevirAL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
- Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
- Absence of cirrhosis
- Screening laboratory values within defined thresholds
- Must use specific contraceptive methods if female of childbearing potential or sexually active male
Key exclusion criteria (5 listed)
- Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
- Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
- Current or prior history of clinical hepatic decompensation
- History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
- Pregnant or a nursing female
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 |
|---|---|---|
| AL-335AL-335 800 mg (2*400) tablet will be administered once daily. | Drug | Group A, Group B |
| OdalasvirOdalasvir 25 mg tablet will be administered once daily. | Drug | Group A, Group B |
| SimeprevirSimeprevir 75 mg capsule will be administered once daily. | Drug | Group A, Group B |
Primary outcome
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
Time frame: Week 12 (Follow-Up Phase)
The SVR 12 was defined as hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.
5 secondary outcomes
Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
Time frame: Week 24 (Follow-Up Phase)
Number of Participants With Viral Relapse
Time frame: End of Treatment up to Week 24 (Follow up phase)
Number of Participants With Late Viral Relapse
Time frame: Up to Week 24 (Follow-up Phase)
Percentage of Participants With On-treatment Failure
Time frame: EOT up to Week 12 (Follow up Phase)
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
Time frame: Week 4 (Follow-Up Phase)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
28 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AL-335, Odalasvir and Simeprevir in people with Hepatitis C, Chronic, run by Janssen Research & Development, LLC at 28 sites in 6 countries.
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 5 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Belgium, Canada, Germany, Poland, Spain and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) (time frame: Week 12 (Follow-Up Phase)). 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 20 Nov 2019.