Trial · NCT00211692
Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial
NCT00211692, Phase 3, Completed, Minneapolis Veterans Affairs Medical Center; results first posted 2014-11-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial. Trials, record NCT00211692. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00211692
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Hepatitis C Treatment Naive Genotype 1 Consensus Interferon Trial
- NCT number
- NCT00211692
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 64 participants, actual
- Lead sponsor
- Minneapolis Veterans Affairs Medical Center
- Conditions
- Chronic Hepatitis C
- Interventions
- consensus interferon (Interferon Alfacon-1) and ribavirin, Consensus Interferon alfa (CIFN) and ribavirin
- First posted
- 2005-09-21
- Last updated
- 2014-11-21
- Results first posted
- 2014-11-21
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response. | 24 weeks after the end of treatment | Overall sustained virologic response for entire cohort and individual sustained virologic response for different arms of study |
| Secondary | Number of Participants Discontinuing Early From Study Treatment | through end of study up to 72 weeks | |
| Secondary | Participants Achieving SVR Categorized by Time of Response | 24 weeks after end of treatment | rapid virologic response assessed at 4 weeks, early virologic response assessed at 8-12 weeks, late virologic response assessed at 16-24 weeks |
| Secondary | Overall Number of Serious Adverse Events | through end of study up to 72 weeks |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response. | 24 weeks after the end of treatment | Convenience sample for pilot trial. Analysis is intention to treat. | participants | NUMBER |
| SECONDARY | Number of Participants Discontinuing Early From Study Treatment | through end of study up to 72 weeks | participants | NUMBER | |
| SECONDARY | Participants Achieving SVR Categorized by Time of Response | 24 weeks after end of treatment | participants with analyzable data for this outcome | participants | NUMBER |
| SECONDARY | Overall Number of Serious Adverse Events | through end of study up to 72 weeks | participants | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response. | A (52 Weeks Treatment) | 11 | participants | ||
| The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response. | B (Duration Based on Viral Response) | 10 | participants | ||
| Number of Participants Discontinuing Early From Study Treatment | Overall | 26 | participants | ||
| Participants Achieving SVR Categorized by Time of Response | Overall | rapid virologic response (n=20) | 15 | participants | |
| Participants Achieving SVR Categorized by Time of Response | Overall | early virologic response (n=13) | 4 | participants | |
| Participants Achieving SVR Categorized by Time of Response | Overall | late virologic response (n=9) | 2 | participants | |
| Overall Number of Serious Adverse Events | Overall | 2 | 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 | Group A 52 Weeks Treatment | 33 | |
| Overall Study | STARTED | Group B Duration Based on Viral Response | 31 | |
| Overall Study | COMPLETED | Group A 52 Weeks Treatment | 33 | |
| Overall Study | COMPLETED | Group B Duration Based on Viral Response | 31 | |
| Overall Study | NOT COMPLETED | Group A 52 Weeks Treatment | 0 | |
| Overall Study | NOT COMPLETED | Group B Duration Based on Viral Response | 0 |
Source ClinicalTrials.gov
Adverse events5
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 | depression/anxiety | Nervous system disorders | Overall | 4 | 64 | 4 |
| other | cellulitis | Skin and subcutaneous tissue disorders | Overall | 3 | 64 | 3 |
| other | other intolerable side effects | General disorders | Overall | 9 | 64 | 9 |
| serious | encephalopathy | Nervous system disorders | Overall | 1 | 64 | 1 |
| serious | chest pain | General disorders | Overall | 1 | 64 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Overall | ||
| Total, other adverse events | Overall | 16 | 64 |
| Total, serious adverse events | Overall | 2 | 64 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 21221804 | 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 |
|---|
| A (52 Weeks Treatment) vs B (Duration Based on Viral Response): The Primary Endpoint Would be the Number Who Achieve a Sustained Virologic Response. |
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/NCT00211692
GET https://conductscience.org/api/trials/v1/NCT00211692/registered