Hepatitis C, ChronicPhase 2NCT01371604
Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks (MK-2355-005)
A Phase 2 study testing IDX184, Peginterferon alfa-2a (Peg-IFN) and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
Trial summary
The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C, Chronic
- What is being tested?
- IDX184, Peginterferon alfa-2a (Peg-IFN) and Ribavirin (RBV)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Oct 2014
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females with documented genotype 1, chronic hepatitis C infection.
- Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
- Has not received prior antiviral treatment for HCV.
- Written informed consent by participant.
Who cannot join
- Pregnant or breastfeeding.
- Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV).
About this study
Official title: A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection
The purpose of this study is to assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.
- Conditions
- Hepatitis C, Chronic
- Being tested
- IDX184, Peginterferon alfa-2a (Peg-IFN), Ribavirin (RBV), Placebo
- Keywords
- Hepatitis C, HCV, treatment-naive
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IDX184Drug
IDX184 50 mg tablet administered orally
Peginterferon alfa-2a (Peg-IFN)Biological
Also called Pegasys
Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
Ribavirin (RBV)Drug
Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.
PlaceboDrug
Matching placebo to IDX184 50 mg tablet administered orally
| Study group | Role | What they receive |
|---|---|---|
| IDX184 50 mg + Peg-IFN/RBV | Experimental | IDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. Receives: Drug: IDX184; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: Ribavirin (RBV); Drug: Placebo |
| IDX184 100 mg + Peg-IFN/RBV | Experimental | IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. Receives: Drug: IDX184; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: Ribavirin (RBV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants who experience a serious adverse event
Measured: Up to Week 16 and end of treatment (Weeks 24 or 48)
Percentage of participants who experience an adverse event
Measured: 16 weeks
Percentage of participants who experience a grade 1-4 laboratory abnormality
Measured: 16 weeks
Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12
Measured: Week 12
Secondary outcomes (6)
Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4
Measured: Week 4
Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment
Measured: Weeks 24 or 48
Percentage of participants who achieve sustained virologic response (SVR)
Measured: 24 weeks after the last dose (Weeks 48 or 72)
Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4
Measured: Week 4
Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment
Measured: Weeks 24 or 48
Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)
Measured: Weeks 48 or 72
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01371604
- Sponsor's protocol ID
- 2355-005
- Other IDs
- IDX-08C-005, 2011-001878-25
- Status last verified
- Feb 2015
- First submitted
- 9 Jun 2011
- Last updated
- 6 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin for 12 Weeks in Treatment-Naïve Subjects With Genotype 1 Chronic Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01371604
- Acronym / sponsor ID
- 2355-005
- Conditions
- Hepatitis C, Chronic
- Keywords
- Hepatitis C, HCV, treatment-naive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 13 Jun 2011 (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 assess the safety and antiviral activity of IDX184 in combination with pegylated interferon and ribavirin in treatment-naïve subjects with genotype 1 chronic hepatitis C virus (HCV) infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IDX184 50 mg + Peg-IFN/RBV | Experimental | Drug: IDX184, Biological: Peginterferon alfa-2a (Peg-IFN), Drug: Ribavirin (RBV), Drug: PlaceboIDX184 50 mg and matching placebo once daily plus peginterferon alfa-2a (Peg-IFN) weekly and ribavirin (RBV) daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. |
| IDX184 100 mg + Peg-IFN/RBV | Experimental | Drug: IDX184, Biological: Peginterferon alfa-2a (Peg-IFN), Drug: Ribavirin (RBV)IDX184 100 mg once daily plus Peg-IFN weekly and RBV daily for 12 weeks followed by Peg-IFN weekly and RBV daily for an additional 12 or 36 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females with documented genotype 1, chronic hepatitis C infection.
- Must agree to use double-barrier method of birth control for at least 6 months after the last dose of study drugs.
- Has not received prior antiviral treatment for HCV.
- Written informed consent by participant.
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding.
- Co-infected with hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV).
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 |
|---|---|---|
| IDX184IDX184 50 mg tablet administered orally | Drug | IDX184 100 mg + Peg-IFN/RBV, IDX184 50 mg + Peg-IFN/RBV |
| Peginterferon alfa-2a (Peg-IFN)Also: PegasysPeginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly | Biological | IDX184 100 mg + Peg-IFN/RBV, IDX184 50 mg + Peg-IFN/RBV |
| Ribavirin (RBV)Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight. | Drug | IDX184 100 mg + Peg-IFN/RBV, IDX184 50 mg + Peg-IFN/RBV |
| PlaceboMatching placebo to IDX184 50 mg tablet administered orally | Drug | IDX184 50 mg + Peg-IFN/RBV |
Primary outcome
Percentage of participants who experience a serious adverse event
Time frame: Up to Week 16 and end of treatment (Weeks 24 or 48)
Percentage of participants who experience an adverse event
Time frame: 16 weeks
Percentage of participants who experience a grade 1-4 laboratory abnormality
Time frame: 16 weeks
Percentage of participants who achieve undetectable HCV ribonucleic acid (RNA) viral levels at Week 12
Time frame: Week 12
6 secondary outcomes
Percentage of participants who achieve undetectable HCV RNA viral levels at Week 4
Time frame: Week 4
Percentage of participants who achieve undetectable HCV RNA viral levels at the end of treatment
Time frame: Weeks 24 or 48
Percentage of participants who achieve sustained virologic response (SVR)
Time frame: 24 weeks after the last dose (Weeks 48 or 72)
Percentage of participants who achieve HCV RNA viral levels below the lower level of quantification (LLOQ) at Week 4
Time frame: Week 4
Percentage of participants who achieve HCV RNA viral levels below LLOQ at the end of treatment
Time frame: Weeks 24 or 48
Percentage of participants who achieve HCV RNA viral levels below LLOQ at follow-up (24 weeks after the last dose)
Time frame: Weeks 48 or 72
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 6 Feb 2015.
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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.
Medical Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IDX184, Peginterferon alfa-2a (Peg-IFN) and Ribavirin (RBV) in people with Hepatitis C, Chronic, run by Merck Sharp & Dohme LLC.
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 2 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 6 Feb 2015. 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 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?
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?
Percentage of participants who experience a serious adverse event (time frame: Up to Week 16 and end of treatment (Weeks 24 or 48)). The study lists 4 primary outcomes in all. 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 6 Feb 2015.