Chronic Hepatitis CPhase 2NCT00120861
Valopicitabine Alone and Together With Pegylated Interferon in Patients With Chronic Hepatitis C Who Have Failed to Respond to Standard Therapy
A Phase 2 study testing valopicitabine, pegylated interferon and ribavirin in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC at 11 sites in United States.
Trial summary
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- valopicitabine, pegylated interferon and ribavirin
- How many people
- Not given
- Where
- 11 sitesUnited States
- Study dates
- Jan 2005to not given
- 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
- Adult, Older adult
Who may be able to join
- Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin
- Other protocol-defined inclusion criteria may apply.
Who cannot join
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis B or HIV
- Other protocol-defined exclusion criteria may apply.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Study site
Baltimore, Maryland
Study site
Birmingham, Alabama
Study site
Boston, Massachusetts
Study site
Dallas, Texas
Study site
Detroit, Michigan
Study site
Houston, Texas
Study site
Los Angeles, California
Study site
Miami, Florida
Study site
New York, New York
Study site
San Antonio, Texas
Study site
San Francisco, California
About this study
Official title: A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.
- Conditions
- Chronic Hepatitis C
- Being tested
- valopicitabine, pegylated interferon, ribavirin
- Keywords
- Genotype-1, Previously failed treatment
- 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.
valopicitabineDrug
pegylated interferonDrug
ribavirinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2005 (estimated)
- Study startJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies 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
- None (open label)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00120861
- Sponsor's protocol ID
- NV-08A-004
- Status last verified
- Jun 2010
- First submitted
- 11 Jul 2005
- Last updated
- 10 Jun 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Phase IIb Clinical Trial to Evaluate the Safety and Antiviral Activity of NM283 and the Combination of Pegylated Interferon Plus NM283, in Patients With Chronic Hepatitis C Who Have Previously Failed to Respond to Standard Therapy
- ClinicalTrials.gov ID
- NCT00120861
- Acronym / sponsor ID
- NV-08A-004
- Conditions
- Chronic Hepatitis C
- Keywords
- Genotype-1, Previously failed treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- First posted
- 19 Jul 2005 (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.
This study is being conducted to compare the safety, effectiveness and tolerance of valopicitabine (NM283) when used alone and when valopicitabine is used together with pegylated interferon in hepatitis C treatment failure patients. These results will be compared against the results of treatment with pegylated interferon plus ribavirin, the current standard therapy for treatment of hepatitis C viral infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented clinical history compatible with chronic hepatitis C and compensated liver disease
- Failed response to previous hepatitis C therapy of pegylated interferon/ribavirin
- Other protocol-defined inclusion criteria may apply.
Key exclusion criteria (3 listed)
- Patient is pregnant or breastfeeding
- Patient is co-infected with hepatitis B or HIV
- Other protocol-defined exclusion criteria may apply.
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 |
|---|---|---|
| valopicitabine | Drug | – |
| pegylated interferon | Drug | – |
| ribavirin | Drug | – |
Primary outcome
Not reported in the source record.
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 10 Jun 2010.
Related trials for Chronic Hepatitis C
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.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing valopicitabine, pegylated interferon and ribavirin in people with Chronic Hepatitis C, run by Merck Sharp & Dohme LLC at 11 sites in United States.
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 3 inclusion and 3 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 10 Jun 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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?
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.
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 10 Jun 2010.