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Chronic Hepatitis C InfectionPhase 2NCT01011166

Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin (MK-2355-004)

A Phase 2 study testing IDX184, Peginterferon alfa-2a (Peg-IFN) and Ribavirin (RBV) in people with Chronic Hepatitis C Infection, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Hepatitis C Infection
What is being tested?
IDX184, Peginterferon alfa-2a (Peg-IFN) and Ribavirin (RBV)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
81 participants
Where
No sites listed yet
Study dates
Nov 2009to Jul 2010
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

  • Has documented chronic HCV GT1 infection
  • Agrees to use of double-barrier contraception and males agree not to donate sperm from the first dose of study therapy through at least 6 months after the final dose of study therapy

Who cannot join

  • Has received previous antiviral treatment for HCV infection
  • Has cirrhosis or decompensated liver disease
  • Is pregnant or breastfeeding
  • Is co-infected with hepatitis B virus (e.g., hepatitis B surface antigen [HBsAg] positive) and/or human immunodeficiency virus (HIV)
  • Has clinically significant concomitant disease

About this study

Official title: A Phase II, Randomized, Double-Blind Study to Evaluate the Safety and Antiviral Activity of IDX184 in Combination With Pegylated Interferon and Ribavirin in Subjects With Genotype 1 Chronic Hepatitis C Infection

This study will assess short term safety, antiviral activity and pharmacokinetics (PK) of IDX184 in combination with Peg-interferon (Peg-IFN)/Ribavirin (RBV) in participants with hepatitis C virus (HCV) genotype (GT) 1 infection. These data will guide dose selection for future, longer term studies.

Being tested
IDX184, Placebo, Peginterferon alfa-2a (Peg-IFN), Ribavirin (RBV)
Keywords
Chronic Hepatitis C, HepC, Hep C
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.

  • IDX184Drug

    IDX184 50 mg white opaque capsules taken by mouth from Day 1 to Day 14.

  • PlaceboDrug

    Placebo white opaque capsules taken by mouth from Day 1 to Day 14.

  • Peginterferon alfa-2a (Peg-IFN)Biological

    Also called Pegasys

    Peg-IFN was supplied as 180 ug single-use, pre-filled syringes administered once weekly from Day 1 to Day 28.

  • Ribavirin (RBV)Drug

    RBV 200 mg capsules at a total daily dose of 1000 mg to 1200 mg (based on participant body weight) from Day 1 to Day 28.

Study groups in NCT01011166
Study groupRoleWhat they receive
IDX184 50 mg QD + Peg-IFN/RBVExperimentalParticipants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo once daily (QD) in combination with Peg-IFN/RBV on Days 14-28 and Peg-IFN/RBV on Days 14-28.
Receives: Drug: IDX184; Drug: Placebo; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: Ribavirin (RBV)
IDX184 100 mg QD + Peg-IFN/RBVExperimentalParticipants randomized 4:1 (active:placebo) to receive IDX184 50 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
Receives: Drug: IDX184; Drug: Placebo; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: Ribavirin (RBV)
IDX184 100 mg BID + Peg-IFN/RBVExperimentalParticipants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo twice daily (BID) in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV alone on Days 14-28.
Receives: Drug: IDX184; Drug: Placebo; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: Ribavirin (RBV)
IDX184 150 mg QD + Peg-IFN/RBVExperimentalParticipants randomized 4:1 (active:placebo) to receive IDX184 150 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
Receives: Drug: IDX184; Drug: Placebo; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: Ribavirin (RBV)
IDX184 200 mg QD + Peg-IFN/RBVExperimentalParticipants randomized 4:1 (active:placebo) to receive IDX184 100 mg or placebo QD in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
Receives: Drug: IDX184; Drug: Placebo; Biological: Peginterferon alfa-2a (Peg-IFN); Drug: Ribavirin (RBV)
IDX184 200 mg BID + Peg-IFN/RBVExperimentalParticipants randomized 4:1 (active:placebo) to receive IDX184 200 mg or placebo BID in combination with Peg-IFN/RBV on Days 1-14 and Peg-IFN/RBV on Days 14-28.
Receives: Drug: IDX184; Drug: Placebo; 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.

  1. Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15

    Measured: Baseline and Day 15

  2. Percentage of participants experiencing adverse events (AEs)

    Measured: Up to 28 days

  3. Percentage of participants experiencing serious adverse events (SAEs)

    Measured: Up to 28 days

  4. Percentage of participants experiencing dose-limiting toxicities (DLTs)

    Measured: Up to 28 days

  5. Percentage of participants experiencing Grade 1-4 laboratory abnormalities

    Measured: Up to 28 days

Secondary outcomes (12)

  1. Change in HCV RNA level from Baseline to Day 28

    Measured: Baseline and Day 28

  2. Percentage of participants with undetectable HCV RNA at Day 15

    Measured: Day 15

  3. Percentage of participants with undetectable HCV RNA at Day 28

    Measured: Day 28

  4. Percentage of participants experiencing virologic breakthrough while on study therapy

    Measured: Up to 28 days

  5. Change in alanine aminotransferase (ALT) level from Baseline to Day 15

    Measured: Baseline and Day 15

  6. Change in ALT level from Baseline to Day 28

    Measured: Baseline and Day 28

  7. Maximum concentration (Cmax)

    Measured: Up to 28 days

  8. Time to maximum concentration (Tmax)

    Measured: Up to 28 days

  9. Area under the drug concentration-time curve (AUC) from time 0 to last measurable concentration (AUC0-t)

    Measured: Up to 28 days

  10. AUC from time zero to infinity (AUC0-~)

    Measured: Up to 28 days

  11. Trough concentration (Ctrough)

    Measured: Up to 28 days

  12. Observed terminal half-life (Thalf)

    Measured: Up to 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2009 (estimated)
  2. Study startNov 2009
  3. Primary completionJul 2010
  4. Study completionJul 2010

Resources

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
Factorial
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
81 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01011166
Sponsor's protocol ID
2355-004
Other IDs
IDX-08C-004
Status last verified
Apr 2015
First submitted
2 Oct 2009
Last updated
23 Apr 2015
Results posted
No
Data monitoring committee
No

Publications

  • Lalezari J, Box T, O'Riordan W, Mehra P, Nguyen T, Poordad F, Dejesus E, Kwo P, Godofsky E, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. IDX184 in combination with pegylated interferon-alpha2a and ribavirin for 2 weeks in treatment-naive patients with chronic hepatitis C. Antivir Ther. 2013;18(6):755-64. doi: 10.3851/IMP2552. Epub 2013 Feb 25.

    PubMed 23439365

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 Chronic Hepatitis C Infection, 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 2 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 23 Apr 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?

Change in HCV ribonucleic acid (RNA) level from Baseline to Day 15 (time frame: Baseline and Day 15). The study lists 5 primary outcomes in all. 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 NCT01011166, 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 23 Apr 2015.

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