Chronic Hepatitis C (HCV)Phase 1/2NCT00807001

Double-Blind, Dose-Escalation Study of IDX184 in Chronic Hepatitis C Treatment-Naïve Subjects

A Phase 1/2 study testing IDX184 in people with Chronic Hepatitis C (HCV), run by Merck Sharp & Dohme LLC.

Completed

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

Trial summary

This is a proof-of-concept study which will provide data about the safety and antiviral activity of several doses of the investigational drug IDX184 given for 3 days in treatment-naive HCV genotype 1-infected subjects so that optimal doses can be chosen for testing in later studies. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Chronic Hepatitis C (HCV)
What is being tested?: IDX184
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 41 participants
Where: No sites listed yet
Study dates: Dec 2008to Jul 2009
Phase: Phase 1/2
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

18-65 years old
Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
Plasma HCV RNA ≥ 5 log10 IU/mL
HCV genotype 1

Who cannot join

Received prior antiviral treatment for hepatitis C infection
Subject is pregnant or breastfeeding
Body Mass Index (BMI) > 32
Currently abusing alcohol or illicit drugs
Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction
Co-infected with hepatitis B virus (HBV, HBsAg positive) and/or human immunodeficiency virus (HIV)

About this study

Official title: A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected With Genotype 1 Chronic Hepatitis C

Conditions: Chronic Hepatitis C (HCV)
Being tested: IDX184
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
oral dose, active or placebo

Study groups in NCT00807001
Study group	Role	What they receive
Cohort A	Experimental	Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. Receives: Drug: IDX184
Cohort B	Experimental	Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. Receives: Drug: IDX184
Cohort C	Experimental	Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. Receives: Drug: IDX184
Cohort D	Experimental	Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care. Receives: Drug: IDX184

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening
Measured: 17 days

Secondary outcomes (1)

Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)
Measures how much virus is in the blood.
Measured: Baseline to 4 days

Timeline

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

Dec 2008Jul 2009

First posted11 Dec 2008 (estimated)
Study startDec 2008
Primary completionJul 2009
Study completionJul 2009

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Chronic Hepatitis C (HCV)Studies 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 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 41 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00807001
Sponsor's protocol ID: 2355-003
Other IDs: IDX-08C-003
Status last verified: Aug 2016
First submitted: 10 Dec 2008
Last updated: 19 Aug 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Lalezari J, Asmuth D, Casiro A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2012 Dec;56(12):6372-8. doi: 10.1128/AAC.01521-12. Epub 2012 Oct 15.
PubMed 23070151

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Chronic Hepatitis C (HCV) trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I/II, Double-Blind, Dose-Escalation Study to Evaluate the Safety and Antiviral Activity of IDX184 in Treatment-Naïve Subjects Infected With Genotype 1 Chronic Hepatitis C
ClinicalTrials.gov ID: NCT00807001
Acronym / sponsor ID: 2355-003
Conditions: Chronic Hepatitis C (HCV)
Keywords: Hepatitis C, HCV, treatment-naive
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 41 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Dec 2008
Primary completion: Jul 2009 (actual)
Study completion: Jul 2009 (actual)
First posted: 11 Dec 2008 (estimated)
Results: Posted 4 Nov 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
Cohort A	Experimental	Drug: IDX184Subjects randomized 8:2 (active:placebo) to receive one 25 milligrams (mg) capsule of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Cohort B	Experimental	Drug: IDX184Subjects randomized 8:2 (active:placebo) to receive two 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Cohort C	Experimental	Drug: IDX184Subjects randomized 8:2 (active:placebo) to receive three 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.
Cohort D	Experimental	Drug: IDX184Subjects randomized 8:2 (active:placebo) to receive four 25 mg capsules of IDX184 per day for 3 days. Fourteen days after treatment, subjects were offered a course of pegylated interferon and ribavirin according to local standard of care.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

18-65 years old
Subject of childbearing potential must agree to use a consistent form of an acceptable double-barrier method of birth control.
Plasma HCV RNA ≥ 5 log10 IU/mL
HCV genotype 1

Key exclusion criteria (6 listed)

Received prior antiviral treatment for hepatitis C infection
Subject is pregnant or breastfeeding
Body Mass Index (BMI) > 32
Currently abusing alcohol or illicit drugs
Currently receiving methadone, buprenorphine or other drugs for the treatment of opioid addiction

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
IDX184oral dose, active or placebo	Drug	Cohort A, Cohort B, Cohort C, Cohort D

Primary outcome

Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events
Time frame: 17 days
Monitoring of adverse events, physical examination, routine safety laboratory parameters and electrocardiograms. 1=mild, 2=moderate, 3=severe, 4=potentially life-threatening

1 secondary outcome

Antiviral Activity at Day 4. Change in Plasma HCV RNA (Hepatitis C Virus Ribonucleic Acid)
Time frame: Baseline to 4 days

Results and safety

Results posted to the registry on 4 Nov 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	8	8
IDX184 25 mg	8	7
IDX184 50 mg	8	8
IDX184 75 mg	8	8
IDX184 100 mg	9	9

Primary outcome: Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events

Time frame: 17 days. Number. Unit: participants

Measure	Placebo n = 8	IDX184 25 mg n = 8	IDX184 50 mg n = 8	IDX184 75 mg n = 8	IDX184 100 mg n = 9
Number of subjects with any adverse event	5	2	3	3	5
Number of sub. with any Grade 3/4 lab abnormality	1	1	0	0	2
Grade 3/4 Triacylglycerol Lipase, high	0	1	0	0	1
Grade 3/4 Prothrombin Intl. Normalized Ratio, high	0	0	0	0	1
Grade 3/4 Prothrombin Time, high	0	0	0	0	1
Grade 3/4 Urine Erythrocytes, high	0	0	0	0	1
Grade 3/4 Pancreatic Amylase, high	1	0	0	0	0

Population analysed: Safety population consisted of all subjects who received at least one dose of study drug.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 17 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 8 (0%)	5 of 8 (62.5%)	Not reported
IDX184 25 mg	0 of 8 (0%)	2 of 8 (25%)	Not reported
IDX184 50 mg	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
IDX184 75 mg	0 of 8 (0%)	3 of 8 (37.5%)	Not reported
IDX184 100 mg	0 of 9 (0%)	5 of 9 (55.6%)	Not reported

Limitations and caveats (from the sponsor): Adverse events summarized the 3 days of IDX184 dosing and 14 days of treatment free follow up.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23070151Lalezari J, Asmuth D, Casiro A, Vargas H, Lawrence S, Dubuc-Patrick G, Chen J, McCarville J, Pietropaolo K, Zhou XJ, Sullivan-Bolyai J, Mayers D. Short-term monotherapy with IDX184, a liver-targeted nucleotide polymerase inhibitor, in patients with chronic hepatitis C virus infection. Antimicrob Agents Chemother. 2012 Dec;56(12):6372-8. doi: 10.1128/AAC.01521-12. Epub 2012 Oct 15.

Related trials for Chronic Hepatitis C (HCV)

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IDX184 in people with Chronic Hepatitis C (HCV), 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 6 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 19 Aug 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 4 Nov 2010). 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?

Number of Subjects With Any Adverse Event (Side Effect) and the Severity of Those Adverse Events (time frame: 17 days). 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 NCT00807001, 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 19 Aug 2016.