Trial · NCT00006164
Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
NCT00006164, Phase 3, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2009-09-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment. Trials, record NCT00006164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00006164
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long Term Interferon for Patients Who Did Not Clear Hepatitis C Virus With Standard Treatment
- NCT number
- NCT00006164
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,050 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Chronic Hepatitis c, Cirrhosis, Liver, Fibrosis, Liver, Hepatic Cirrhosis
- Interventions
- Peginterferon alfa-2a + Ribavirin, Peginterferon alfa-2a
- First posted
- 2000-08-09
- Last updated
- 2020-05-12
- Results first posted
- 2009-09-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points | 1400 days (3.85 years) post randomization | Progression of liver disease within 1400 days as indicated by death, hepatic decompensation (variceal hemorrhage; ascites; spontaneous bacterial peritonitis; hepatic encephalopathy), hepatocellular carcinoma, a Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater decompensation), or for patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study |
| Primary | Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies | 1400 days (3.85 years) post randomization | For patients with noncirrhotic fibrosis at baseline, an increase in Ishak hepatic fibrosis score (range 0-6, higher score indicates greater fibrosis) of at least 2 points by assessment of a liver-biopsy specimen obtained during the study (collected at Year 2 and Year 4 biopsies, 1.5 and 3.5 years after randomization) |
| Primary | Death From Any Cause | 1400 days (3.85 years) post randomization | |
| Primary | Development of Hepatocellular Carcinoma (HCC) | 1400 days (3.85 years) post randomization | A diagnosis of development of hepatocellular carcinoma (HCC) was based on either 1. Histology showing HCC (from a biopsy, surgery, or autopsy) or 2. A new hepatic defect on imaging with an alpha-fetoproteion (AFP) level rising to \> 1,000 ng/ml. |
| Primary | Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits | 1400 days (3.85 years) post randomization | Child-Turcotte-Pugh (CTP) score of 7 or more on two consecutive study visits (score range 5-15, higher score indicates greater hepatic decompensation) |
| Primary | Variceal Hemorrhage | 1400 days (3.85 years) post randomization | A gastrointestinal hemorrhage which is believed by the investigator to be due to bleeding esophageal or gastric varices. In general, an endoscopy will have been performed and will have revealed either direct evidence of variceal bleeding (bleeding varix, red wale sign) or historical evidence for significant upper gastro-intestinal bleeding plus upper endoscopy revealing moderate varices and no other site of bleeding is identified |
| Primary | Ascites | 1400 days (3.85 years) post randomization | Any abdominal fluid which is: 1. Mild, moderate or marked on ultrasound; or 2. Progressive on serial physical examinations; or 3. Requires diuretic therapy. To meet the definition of ascites, abdominal fluid that is "mild" ("barely detectable") on physical examination requires ultrasound confirmation that is "mild", "moderate" or "marked" ascites. Ultrasound reports of minimal fluid around the liver do not meet the definition. |
| Primary | Spontaneous Bacterial Peritonitis | 1400 days (3.85 years) post randomization | Any episode of spontaneous ascitic infection diagnosed on the basis of elevated neutrophil count (\> 250/ml) in paracentesis fluid or positive bacterial cultures and clinical diagnosis in the absence of white blood cell (WBC) availability. |
| Primary | Hepatic Encephalopathy | 1400 days (3.85 years) post randomization | Any mental status alteration which is deemed by the investigator to be due to portosystemic encephalopathy, whether occurring during a provoked episode (GI bleeding, diuretics, usual sedative doses), or spontaneously (without apparent cause). |
| Secondary | Serious Adverse Events | 1400 days (3.85 years) post randomization | A serious adverse event (SAE) is an untoward medical occurrence that results in any of the following: 1. Death 2. Is life threatening (risk of death at the time of the event) 3. Requires in-patient hospitalization or prolongation of existing hospitalization 4. Results in persistent or significant disability/incapacity 5. Congenital abnormality or birth defect Trial outcomes (except death) were not considered serious adverse events. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies | 1400 days (3.85 years) post randomization | Patients with Ishak fibrosis score \<5 at baseline and at least one follow-up biopsy | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Death From Any Cause | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Development of Hepatocellular Carcinoma (HCC) | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Variceal Hemorrhage | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Ascites | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Spontaneous Bacterial Peritonitis | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Hepatic Encephalopathy | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Serious Adverse Events | 1400 days (3.85 years) post randomization | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points | Peginterferon Alfa-2a 90 mcg/Week | 157 | Participants | ||
Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular Carcinoma, or for Patients With Noncirrhotic Fibrosis at Baseline, an Increase in the Ishak Hepatic Fibrosis Score of 2 or More Points | Standard of Care Followup | 157 | Participants | ||
| Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies | Peginterferon Alfa-2a 90 mcg/Week | 71 | Participants | ||
| Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies | Standard of Care Followup | 81 | Participants | ||
| Death From Any Cause | Peginterferon Alfa-2a 90 mcg/Week | 31 | Participants | ||
| Death From Any Cause | Standard of Care Followup | 22 | Participants | ||
| Development of Hepatocellular Carcinoma (HCC) | Peginterferon Alfa-2a 90 mcg/Week | 13 | Participants | ||
| Development of Hepatocellular Carcinoma (HCC) | Standard of Care Followup | 16 | Participants | ||
| Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits | Peginterferon Alfa-2a 90 mcg/Week | 57 | Participants | ||
| Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits | Standard of Care Followup | 52 | Participants |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Peginterferon Alfa-2a 90 mcg/Week | 517 | |
| Overall Study | STARTED | Standard of Care Followup | 533 | |
| Overall Study | COMPLETED | Peginterferon Alfa-2a 90 mcg/Week | 447 | |
| Overall Study | COMPLETED | Standard of Care Followup | 452 | |
| Overall Study | NOT COMPLETED | Peginterferon Alfa-2a 90 mcg/Week | 70 | |
| Overall Study | NOT COMPLETED | Standard of Care Followup | 81 |
Source ClinicalTrials.gov
Adverse events146
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 | Anemia | Blood and lymphatic system disorders | Peginterferon Alfa-2a 90 mcg/Week | 26 | 517 | |
| other | Anemia | Blood and lymphatic system disorders | Standard of Care Followup | 11 | 533 | |
| other | Hypertension | Cardiac disorders | Peginterferon Alfa-2a 90 mcg/Week | 42 | 517 | |
| other | Hypertension | Cardiac disorders | Standard of Care Followup | 46 | 533 | |
| other | Diabetes | Endocrine disorders | Peginterferon Alfa-2a 90 mcg/Week | 33 | 517 | |
| other | Diabetes | Endocrine disorders | Standard of Care Followup | 56 | 533 | |
| other | Sexual dysfunction, impotence | Reproductive system and breast disorders | Peginterferon Alfa-2a 90 mcg/Week | 28 | 517 | |
| other | Sexual dysfunction, impotence | Reproductive system and breast disorders | Standard of Care Followup | 12 | 533 | |
| other | Cystitis, bladder infection | Infections and infestations | Peginterferon Alfa-2a 90 mcg/Week | 41 | 517 | |
| other | Cystitis, bladder infection | Infections and infestations | Standard of Care Followup | 28 | 533 |
1 to 10 of 146Source ClinicalTrials.gov
See all 146 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Peginterferon Alfa-2a 90 mcg/Week | ||
| Total, all-cause mortality | Standard of Care Followup | ||
| Total, other adverse events | Peginterferon Alfa-2a 90 mcg/Week | 486 | 517 |
| Total, other adverse events | Standard of Care Followup | 492 | 533 |
| Total, serious adverse events | Peginterferon Alfa-2a 90 mcg/Week | 175 | 517 |
| Total, serious adverse events | Standard of Care Followup | 155 | 533 |
Source ClinicalTrials.gov
Papers36
The papers the trial lists on ClinicalTrials.gov.
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 comparisons12
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Serious Adverse Events | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Development of Hepatocellular Carcinoma (HCC) | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Variceal Hemorrhage | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Increase in Ishak Fibrosis Score by 2 Points or More at 2 or 4 Year Biopsies | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Ascites | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Presumed Hepatocellular Carcinoma (HCC) | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Death From Any Cause | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Spontaneous Bacterial Peritonitis | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Child-Turcotte-Pugh (CTP) Score of 7 or Higher at Two Consecutive Study Visits | Trial comparisons |
| Peginterferon Alfa-2a 90 mcg/Week vs Standard of Care Followup: Hepatic Encephalopathy | Trial comparisons |
1 to 10 of 12
See all 12 trial comparisonsTests0
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/NCT00006164
GET https://conductscience.org/api/trials/v1/NCT00006164/results?page=2