Trial · NCT00724451
Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
NCT00724451, Completed, Merck Sharp & Dohme LLC; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1). Trials, record NCT00724451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00724451
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Observational Study Assessing Chronic Hepatitis C Management in Clinical Practice in Italy (Study P05488 AM1)
- NCT number
- NCT00724451
- Status
- Completed
- Enrollment
- 1,128 participants, actual
- Lead sponsor
- Merck Sharp & Dohme LLC
- Conditions
- Hepatitis C, Hepatitis C, Chronic
- Interventions
- Peginterferon alfa-2b, Ribavirin, Peginterferon alfa-2a
- First posted
- 2008-07-29
- Last updated
- 2015-09-25
- Results first posted
- 2012-10-31
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Measured at baseline | Investigators recorded their reasons for not prescribing anti-viral treatment. More than one reason leading to non-eligibility could be presented for the same participant. |
| Secondary | Number of Participants Discontinued From Treatment by Reason for Discontinuation | 24 weeks after the end of treatment (total of 48 to 72 weeks) | Investigators recorded reasons for treatment discontinuation. |
| Secondary | Number of Participants With Treatment Failure by Reason for Failure | 24 to 48 weeks | Investigators recorded reasons for treatment failure whether or not treatment was completed. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Measured at baseline | 431 of the 1118 participants were determined to be non-eligible for antiviral therapy by Investigator decision. | participants | NUMBER |
| SECONDARY | Number of Participants Discontinued From Treatment by Reason for Discontinuation | 24 weeks after the end of treatment (total of 48 to 72 weeks) | Reasons for treatment discontinuations were recorded by Investigators for 174 of the 500 treated participants. | participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Failure by Reason for Failure | 24 to 48 weeks | 132 of the 500 treated participants failed treatment per Investigator assessment. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group17
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Age | 144 | participants | |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Mild disease | 77 | participants | |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Substance abuse history | 17 | participants | |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Treatment postponed | 7 | participants | |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Genotype | 2 | participants | |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Comorbidity | 139 | participants | |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Liver problems | 41 | participants | |
| Number of Participants Not Eligible for Antiviral Treatment by Reason for Non-eligibility | Participants With Chronic Hepatitis C (CHC) | Problems with previous treatment | 4 | participants | |
| Number of Participants Discontinued From Treatment by Reason for Discontinuation | Participants With Chronic Hepatitis C (CHC) | Disease worsening | 3 | participants | |
| Number of Participants Discontinued From Treatment by Reason for Discontinuation | Participants With Chronic Hepatitis C (CHC) | Side effects | 27 | participants |
1 to 10 of 17Source ClinicalTrials.gov
See all 17 results by groupParticipant flow4
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Participants With Chronic Hepatitis C (CHC) | 1,128 | |
| Overall Study | Received Antiviral Treatment | Participants With Chronic Hepatitis C (CHC) | 500 | |
| Overall Study | COMPLETED | Participants With Chronic Hepatitis C (CHC) | 326 | |
| Overall Study | NOT COMPLETED | Participants With Chronic Hepatitis C (CHC) | 802 |
Source ClinicalTrials.gov
Adverse events108
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 | Participants With Chronic Hepatitis C (CHC) | 64 | 500 | 65 |
| other | Haemoglobinaemia | Blood and lymphatic system disorders | Participants With Chronic Hepatitis C (CHC) | 1 | 500 | 1 |
| other | Leukopenia | Blood and lymphatic system disorders | Participants With Chronic Hepatitis C (CHC) | 10 | 500 | 10 |
| other | Neutropenia | Blood and lymphatic system disorders | Participants With Chronic Hepatitis C (CHC) | 23 | 500 | 23 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Participants With Chronic Hepatitis C (CHC) | 5 | 500 | 5 |
| other | Tachycardia | Cardiac disorders | Participants With Chronic Hepatitis C (CHC) | 3 | 500 | 3 |
| other | Deafness | Ear and labyrinth disorders | Participants With Chronic Hepatitis C (CHC) | 1 | 500 | 1 |
| other | Autoimmune thyroiditis | Endocrine disorders | Participants With Chronic Hepatitis C (CHC) | 2 | 500 | 2 |
| other | Hyperthyroidism | Endocrine disorders | Participants With Chronic Hepatitis C (CHC) | 4 | 500 | 4 |
| other | Hypothyroidism | Endocrine disorders | Participants With Chronic Hepatitis C (CHC) | 7 | 500 | 7 |
1 to 10 of 108Source ClinicalTrials.gov
See all 108 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Participants With Chronic Hepatitis C (CHC) | ||
| Total, other adverse events | Participants With Chronic Hepatitis C (CHC) | 169 | 500 |
| Total, serious adverse events | Participants With Chronic Hepatitis C (CHC) | 6 | 500 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25483909 | DERIVED |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00724451
GET https://conductscience.org/api/trials/v1/NCT00724451/events?page=2