Hepatitis C, ChronicAPEGINNCT00724854
Evaluation of Rapid Virologic Response Among HCV Patients Treated With PegIntron and Rebetol in Brazil (Study P05427)
An observational study of Hepatitis C, Chronic and Hepatitis C, run by Merck Sharp & Dohme LLC.
Trial summary
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis C, Chronic, Hepatitis C
- What is being tested?
- PegIntron (peginterferon alfa-2b; SCH 54031) and Rebetol (ribavirin; SCH 18908)
- How many people
- 1,146 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Sep 2009
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants infected with Hepatitis C Virus (HCV) who are undergoing treatment with PegIntron and Rebetol in accordance with approved labeling at approximately 60 sites in Brazil. Participants could be treatment-naïve, undergoing re-treatment, or co-infected with Human Immunodeficiency Virus (HIV).
Who may be able to join
- Willing to participate in the study and sign the Informed Consent Form
- Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [PCR] test)
- Can be treatment-naïve, have retreatment, or co-infected with HIV
- Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit
Who cannot join
- Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form
- Prior treatment with PegIntron (combined with ribavirin or not)
- History of alcohol abuse in the past 6 months
- Decompensated liver disease
- Severe heart disease
- Decompensated thyroid disorder
Show all 13Show fewer
- Neoplasia
- Type 1 diabetes mellitus - uncontrolled or hardly controlled
- Seizures - uncontrolled
- Primary immune deficiency
- Men and women not using appropriate contraceptive methods
- Pregnancy or lactation
- For participants co-infected with HIV: HIV-related opportunistic disease in the past 6 months or CD4 count lower than 200 cells/mm^3
About this study
Official title: Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Being tested
- PegIntron (peginterferon alfa-2b; SCH 54031), Rebetol (ribavirin; SCH 18908)
- 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.
PegIntron (peginterferon alfa-2b; SCH 54031)Biological
Also called SCH 54031
PegIntron administered in accordance with approved labeling
Rebetol (ribavirin; SCH 18908)Drug
Also called SCH 18908
Rebetol administered in accordance with approved labeling
| Study group | Role | What they receive |
|---|---|---|
| Mono-infected with HCV | Participants infected with Hepatitis C Virus (HCV). Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908) | |
| Co-infected with HCV and HIV | Participants co-infected with HCV and Human Immunodeficiency Virus (HIV). Receives: Biological: PegIntron (peginterferon alfa-2b; SCH 54031); Drug: Rebetol (ribavirin; SCH 18908) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
Measured: Assessed at Treatment Week 4
Secondary outcomes (4)
Number of Participants Who Achieved Sustained Virologic Response (SVR)
SVR was defined as non-detectable HCV RNA 24 weeks post-treatment.
Measured: Assessed at 24 weeks post-treatment
Number of Participants With RVR Who Also Achieved SVR
RVR was defined as HCV RNA negative after 4 weeks of treatment. SVR was defined as non-detectable HCV RNA 24 weeks or more post-treatment.
Measured: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)
Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR
Participants who achieved RVR at Treatment Week 4 who were considered to have SVR (non-detectable HCV RNA at Treatment Week 48 for genotypes 2 and 3, and Treatment Week 72 for genotypes 1, 4, and 5). Participants from the Mono-infected with HCV group and the Co-infected with HCV and HIV group, were identified as either Genotype 1, 2, 3, 4, or 5.
Measured: Treatment Week 48 and Treatment Week 72
Assessment of Baseline Characteristics in Participants With SVR
Baseline characteristics assessed were age, gender, and genotype.
Measured: 24 Weeks post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startAug 2006
- Primary completionSep 2009
- Study completionSep 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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00724854
- Sponsor's protocol ID
- P05427
- Other IDs
- 001/05
- Acronym
- APEGIN
- Status last verified
- Feb 2015
- First submitted
- 25 Jul 2008
- Last updated
- 25 Feb 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Santos C, Reis A, Dos Santos CV, Damas C, Silva MH, Viana MV, Ferraz ML, Carnauba D, El-Far F, Serra F, Diaz RS. The use of real-time PCR to detect hepatitis C virus RNA in dried blood spots from Brazilian patients infected chronically. J Virol Methods. 2012 Jan;179(1):17-20. doi: 10.1016/j.jviromet.2011.06.012. Epub 2011 Jun 24.
PubMed 21871496
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Rapid Virological Response in HCV Patients Treated With PegIntron and Ribavirin - APEGIN Trial
- ClinicalTrials.gov ID
- NCT00724854
- Acronym / sponsor ID
- APEGIN / P05427
- Conditions
- Hepatitis C, Chronic, Hepatitis C
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,146 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 30 Jul 2008 (estimated)
- Results
- Posted 10 Jan 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of the study is to evaluate, in each group, the number of participants who achieve rapid virological response (RVR) after 4 weeks treatment with PegIntron and Rebetol. The study will also assess whether RVR is a reliable predictor of sustained virologic response (defined as undetectable viral load at 24 weeks post-treatment).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mono-infected with HCV | – | Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908)Participants infected with Hepatitis C Virus (HCV). |
| Co-infected with HCV and HIV | – | Biological: PegIntron (peginterferon alfa-2b; SCH 54031), Drug: Rebetol (ribavirin; SCH 18908)Participants co-infected with HCV and Human Immunodeficiency Virus (HIV). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants infected with Hepatitis C Virus (HCV) who are undergoing treatment with PegIntron and Rebetol in accordance with approved labeling at approximately 60 sites in Brazil. Participants could be treatment-naïve, undergoing re-treatment, or co-infected with Human Immunodeficiency Virus (HIV).
Key inclusion criteria (4 listed)
- Willing to participate in the study and sign the Informed Consent Form
- Established HCV infection, confirmed by molecular biology test (positive qualitative polymerase chain reaction [PCR] test)
- Can be treatment-naïve, have retreatment, or co-infected with HIV
- Be under treatment with PegIntron in combination with ribavirin, starting up to 14 days before the screening visit
Key exclusion criteria (13 listed)
- Participants who have not confirmed their willingness to participate in the study or have refused to sign the Free and Informed Consent Form
- Prior treatment with PegIntron (combined with ribavirin or not)
- History of alcohol abuse in the past 6 months
- Decompensated liver disease
- Severe heart disease
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 |
|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031)Also: SCH 54031PegIntron administered in accordance with approved labeling | Biological | Co-infected with HCV and HIV, Mono-infected with HCV |
| Rebetol (ribavirin; SCH 18908)Also: SCH 18908Rebetol administered in accordance with approved labeling | Drug | Co-infected with HCV and HIV, Mono-infected with HCV |
Primary outcome
Number of Participants With Rapid Virologic Response After 4 Weeks of Treatment
Time frame: Assessed at Treatment Week 4
Rapid virologic response (RVR) was defined as Hepatitis C Virus Ribonucleic acid (HCV RNA) negative after 4 weeks of treatment.
4 secondary outcomes
Number of Participants Who Achieved Sustained Virologic Response (SVR)
Time frame: Assessed at 24 weeks post-treatment
Number of Participants With RVR Who Also Achieved SVR
Time frame: Assessed at Treatment Week 4 (RVR) and 24 weeks post-treatment (SVR)
Assessment of Response at Treatment Week 48 for Genotypes 2 and 3, and Treatment Week 72 for Genotypes 1, 4, and 5, in Participants With RVR
Time frame: Treatment Week 48 and Treatment Week 72
Assessment of Baseline Characteristics in Participants With SVR
Time frame: 24 Weeks post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21871496Santos C, Reis A, Dos Santos CV, Damas C, Silva MH, Viana MV, Ferraz ML, Carnauba D, El-Far F, Serra F, Diaz RS. The use of real-time PCR to detect hepatitis C virus RNA in dried blood spots from Brazilian patients infected chronically. J Virol Methods. 2012 Jan;179(1):17-20. doi: 10.1016/j.jviromet.2011.06.012. Epub 2011 Jun 24.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C, Chronic and Hepatitis C, 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 13 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 25 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2011). 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 Participants With Rapid Virologic Response After 4 Weeks of Treatment (time frame: Assessed at Treatment Week 4). 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 NCT00724854, 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 25 Feb 2015.