Trial · NCT00265395
Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)
NCT00265395, Phase 3, Completed, Merck Sharp & Dohme LLC; results first posted 2009-07-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685). Trials, record NCT00265395. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00265395
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extended Treatment With PEG-Intron® and Rebetol® in Patients With Genotype 1 Chronic Hepatitis C and Slow Virologic Response (Study P03685)
- NCT number
- NCT00265395
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,428 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C, Chronic
- Interventions
- Combination of pegylated interferon alfa-2b (PEG-Intron®) and ribavirin (Rebetol®), Combination of pegylated interferon alfa-2b and ribavirin
- First posted
- 2005-12-14
- Last updated
- 2017-04-05
- Results first posted
- 2009-07-08
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. | 48 or 72 weeks of treatment plus 24 weeks of follow-up. | LLQ = 30 IU/mL by reverse transcription polymerase chain reaction (RT-PCR) (Taqman Roche) |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. | 48 or 72 weeks of treatment plus 24 weeks of follow-up. | According to the protocol, the efficacy analysis was carried out on all slow responders (ie, patients who had at least 2 log drop in HCV-RNA level at treatment week 12, and undetectable HCV-RNA at treatment week 24). | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. | Standard Therapy (48-week Treatment) | 37 | Participants | ||
| Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. | Extended Therapy (72-week Treatment) | 35 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Standard Therapy (48-week Treatment) | 86 | |
| Overall Study | STARTED | Extended Therapy (72-week Treatment) | 73 | |
| Overall Study | COMPLETED | Standard Therapy (48-week Treatment) | 78 | |
| Overall Study | COMPLETED | Extended Therapy (72-week Treatment) | 56 | |
| Overall Study | NOT COMPLETED | Standard Therapy (48-week Treatment) | 8 | |
| Overall Study | NOT COMPLETED | Extended Therapy (72-week Treatment) | 17 |
Source ClinicalTrials.gov
Adverse events157
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | ANAEMIA | Blood and lymphatic system disorders | Standard Therapy (48-week Treatment) | 197 | 1,427 | 260 |
| other | ERYTHROPENIA | Blood and lymphatic system disorders | Standard Therapy (48-week Treatment) | 74 | 1,427 | 96 |
| other | LEUKOPENIA | Blood and lymphatic system disorders | Standard Therapy (48-week Treatment) | 183 | 1,427 | 268 |
| other | NEUTROPENIA | Blood and lymphatic system disorders | Standard Therapy (48-week Treatment) | 281 | 1,427 | 464 |
| other | ABDOMINAL PAIN UPPER | Gastrointestinal disorders | Standard Therapy (48-week Treatment) | 94 | 1,427 | 112 |
| other | DIARRHOEA | Gastrointestinal disorders | Standard Therapy (48-week Treatment) | 129 | 1,427 | 152 |
| other | DRY MOUTH | Gastrointestinal disorders | Standard Therapy (48-week Treatment) | 75 | 1,427 | 75 |
| other | NAUSEA | Gastrointestinal disorders | Standard Therapy (48-week Treatment) | 254 | 1,427 | 301 |
| other | ASTHENIA | General disorders | Standard Therapy (48-week Treatment) | 402 | 1,427 | 458 |
| other | CHILLS | General disorders | Standard Therapy (48-week Treatment) | 153 | 1,427 | 204 |
1 to 10 of 157Source ClinicalTrials.gov
See all 157 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Therapy (48-week Treatment) | ||
| Total, other adverse events | Standard Therapy (48-week Treatment) | 1,337 | 1,427 |
| Total, serious adverse events | Standard Therapy (48-week Treatment) | 93 | 1,427 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20683847 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Standard Therapy (48-week Treatment) vs Extended Therapy (72-week Treatment): Sustained Virologic Response, Defined as a Plasma HCV-RNA (Hepatitis C Ribonucleic Acid) Level Below the LLQ (Lower Level of Quantitation) at 24 Weeks Post-treatment. |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00265395
GET https://conductscience.org/api/trials/v1/NCT00265395/events?page=2