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Trial record 19 of 546 for:    "Viral Infectious Disease" | "Peginterferon alfa-2a"

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) Plus COPEGUS (Ribavirin) in Patients With Chronic Hepatitis C (CHC) Genotype 1 and Human Immunodeficiency Virus-1 (HIV-1) Co-infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00353418
Recruitment Status : Completed
First Posted : July 18, 2006
Results First Posted : June 15, 2010
Last Update Posted : August 3, 2010
Sponsor:
Information provided by:
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Peginterferon alfa-2a
Drug: Ribavirin
Enrollment 415
Recruitment Details  
Pre-assignment Details  
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 138 277
Completed 55 119
Not Completed 83 158
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 138 277 415
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 138 participants 277 participants 415 participants
< 65 years 134 273 407
>=65 years 1 2 3
[1]
Measure Description: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 138 participants 277 participants 415 participants
45.2  (8.39) 45.5  (8.16) 45.4  (8.24)
[1]
Measure Description: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Gender   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 138 participants 277 participants 415 participants
Female 29 51 80
Male 106 224 330
[1]
Measure Description: The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
1.Primary Outcome
Title Sustained Virological Response (SVR)
Hide Description SVR was defined by the percentage of patients with undetectable Hepatitis C virus (HCV) ribonucleic acid (RNA) at 24 weeks after completion of the 48-week treatment period (i.e., a single last HCV RNA < 20 IU/mL measured ≥ Day 477 [≥ Week 68]). Patients without an HCV measurement at the end of the 24-week untreated follow-up period were considered nonresponders.
Time Frame Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 135 275
Measure Type: Number
Unit of Measure: Percentage of participants
19 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg, PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Comments

Sample sizes of 133 and 267 patients for RBV 800 mg daily and RBV 1000 or 1200 mg daily, respectively, provided the following probabilities of detecting the specified differences in SVR with a 0.05 level two-sided chi-square test of significance:

RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.40; Probability - 0.49

RBV 800 mg SVR - 0.30; RBV 1000 or 1200 mg SVR - 0.45; Probability - 0.83

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6119
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.15
Confidence Interval 95%
0.68 to 1.93
Estimation Comments [Not Specified]
2.Primary Outcome
Title Incidence of Adverse Events, Dose Reductions and Withdrawals Due to Anemia
Hide Description Adverse events of anemia included hemolytic anemia, aplasia pure red cell, and pancytopenia.
Time Frame Up to Week 72
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 135 274
Measure Type: Number
Unit of Measure: Percentage of participants
Adverse anemic event 24 32
Serious adverse anemic event 4 4
PEG-INF alfa-2a dose modification due to anemia 2 3
Ribavirin dose modification due to anemia 10 18
Premature PEG-INF alfa-2a withdrawal due to anemia 1 3
Premature ribavirin withdrawal due to anemia 2 3
3.Secondary Outcome
Title Virological Response at End of Treatment Period
Hide Description Virological response at the end of the treatment period was defined as a single last HCV RNA measurement <20 IU/mL at the completion of the treatment period (Days 324 to 351). Patients without an HCV measurement at Week 48 were considered nonresponders.
Time Frame Week 48
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 135 275
Measure Type: Number
Unit of Measure: Percentage of participants
30 35
4.Secondary Outcome
Title Virological Response at Weeks 4, 12 and 24
Hide Description Virological response at Weeks 4, 12 and 24 was also defined as a single last undetectable HCV RNA (< 20 IU/mL) falling within the visit windows of Days 16 to 43, 72 to 99, and 156 to 183, respectively. Patients without an HCV measurement at a study week were considered nonresponders at that study week.
Time Frame Weeks 4, 12 and 24
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 135 275
Measure Type: Number
Unit of Measure: Percentage of participants
Week 4 8 7
Week 12 25 25
Week 24 33 40
5.Secondary Outcome
Title Relapse of Virological Response
Hide Description Relapse of virological response was calculated by dividing the number of patients who achieved a virological response at the end of treatment but had detectable HCV RNA at the last assessment posttreatment by the number of patients with a virological response at the end of treatment who had at least one HCV RNA assessment posttreatment.
Time Frame Weeks 48 and 72
Hide Outcome Measure Data
Hide Analysis Population Description
Within the All Patients Treated population, patients with a response at end of treatment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 37 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 83 patients.
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 37 83
Measure Type: Number
Unit of Measure: Percentage of participants
32 36
6.Secondary Outcome
Title Rapid Virological Response (RVR) by Week 4
Hide Description RVR was defined as an undetectable HCV RNA < 20 IU/mL (a single last HCV RNA < 20 IU/mL falling in the time window of Days 2 to 43). Patients without an HCV measurement by Week 4 were considered nonresponders.
Time Frame Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 135 275
Measure Type: Number
Unit of Measure: Percentage of participants
8 7
7.Secondary Outcome
Title Early Virological Response (EVR), Partial EVR and Complete EVR by Week 12
Hide Description EVR: Undetectable HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level, by Week 12 (a single last HCV RNA <20 IU/mL or ≥2 log10 drop from pretreatment level in the time window of Days 2 to 99). Partial EVR: Detectable HCV RNA but ≥2 log10 drop from pretreatment, by Week 12 (a single last HCV RNA detectable but ≥2 log10 drop from pretreatment in the time window of Days 2 to 99). Complete EVR: Undetectable HCV RNA <20 IU/mL, by Week 12 (a single last HCV RNA <20 IU/mL in the time window of Days 2 to 99). Patients without an HCV measurement by Week 12 were considered nonresponders.
Time Frame Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
The All Patients Treated population included all patients randomized who had received at least one dose of study medication: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 275 patients.
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 135 275
Measure Type: Number
Unit of Measure: Percentage of participants
Early Virological Response 51 61
Partial Early Virological Response 25 35
Complete Early Virological Response 26 26
Time Frame [Not Specified]
Adverse Event Reporting Description The Safety population included all patients randomized who received at least one dose of the study medication and had at least one postbaseline safety assessment: PEG-IFN alfa 2-a 180 μg + ribavirin 800 mg = 135 patients; PEG-IFN alfa 2-a 180 μg + ribavirin 1000 or 1200 mg = 274 patients.
 
Arm/Group Title PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   21/135 (15.56%)   46/274 (16.79%) 
Blood and lymphatic system disorders     
Anaemia  5/135 (3.70%)  8/274 (2.92%) 
Haemolytic Anaemia  0/135 (0.00%)  2/274 (0.73%) 
Thrombocytopenia  1/135 (0.74%)  1/274 (0.36%) 
Autoimmune Thrombocytopenia  0/135 (0.00%)  1/274 (0.36%) 
Pancytopenia  1/135 (0.74%)  0/274 (0.00%) 
Cardiac disorders     
Acute Myocardial Infarction  0/135 (0.00%)  1/274 (0.36%) 
Atrial Fibrillation  0/135 (0.00%)  1/274 (0.36%) 
Hypertrophic Cardiomyopathy  1/135 (0.74%)  0/274 (0.00%) 
Myocardial Infarction  1/135 (0.74%)  0/274 (0.00%) 
Pericarditis  0/135 (0.00%)  1/274 (0.36%) 
Eye disorders     
Retinal Detachment  0/135 (0.00%)  1/274 (0.36%) 
Gastrointestinal disorders     
Vomiting  1/135 (0.74%)  1/274 (0.36%) 
Abdominal Pain  0/135 (0.00%)  1/274 (0.36%) 
Colitis  1/135 (0.74%)  0/274 (0.00%) 
Constipation  0/135 (0.00%)  1/274 (0.36%) 
Oesophageal Varices Haemorrhage  0/135 (0.00%)  1/274 (0.36%) 
Pancreatitis  1/135 (0.74%)  0/274 (0.00%) 
Small Intestinal Obstruction  0/135 (0.00%)  1/274 (0.36%) 
General disorders     
Pyrexia  1/135 (0.74%)  0/274 (0.00%) 
Hepatobiliary disorders     
Cholecystitis Acute  0/135 (0.00%)  1/274 (0.36%) 
Cholelithiasis  0/135 (0.00%)  1/274 (0.36%) 
Infections and infestations     
Bronchitis  1/135 (0.74%)  2/274 (0.73%) 
Cellulitis  2/135 (1.48%)  0/274 (0.00%) 
Pneumonia  1/135 (0.74%)  1/274 (0.36%) 
Pneumonia Pneumococcal  1/135 (0.74%)  1/274 (0.36%) 
Staphylococcal Abscess  1/135 (0.74%)  1/274 (0.36%) 
Urinary Tract Infection  0/135 (0.00%)  2/274 (0.73%) 
Anal Abscess  0/135 (0.00%)  1/274 (0.36%) 
Bursitis Infective  0/135 (0.00%)  1/274 (0.36%) 
Carbuncle  1/135 (0.74%)  0/274 (0.00%) 
Gangrene  0/135 (0.00%)  1/274 (0.36%) 
Gastroenteritis  1/135 (0.74%)  0/274 (0.00%) 
Gastroenteritis Viral  0/135 (0.00%)  1/274 (0.36%) 
Herpes Zoster  1/135 (0.74%)  0/274 (0.00%) 
Infected Skin Ulcer  1/135 (0.74%)  0/274 (0.00%) 
Influenza  0/135 (0.00%)  1/274 (0.36%) 
Pneumococcal Bacteraemia  0/135 (0.00%)  1/274 (0.36%) 
Sepsis  0/135 (0.00%)  1/274 (0.36%) 
Subcutaneous Abscess  0/135 (0.00%)  1/274 (0.36%) 
Subdiaphragmatic Abscess  0/135 (0.00%)  1/274 (0.36%) 
Wound Infection  0/135 (0.00%)  1/274 (0.36%) 
Injury, poisoning and procedural complications     
Accidental Overdose  1/135 (0.74%)  0/274 (0.00%) 
Ankle Fracture  0/135 (0.00%)  1/274 (0.36%) 
Multiple Injuries  0/135 (0.00%)  1/274 (0.36%) 
Splenic Injury  0/135 (0.00%)  1/274 (0.36%) 
Metabolism and nutrition disorders     
Abnormal Loss of Weight  0/135 (0.00%)  2/274 (0.73%) 
Dehydration  1/135 (0.74%)  1/274 (0.36%) 
Hyperglycaemia  0/135 (0.00%)  1/274 (0.36%) 
Hyponatraemia  0/135 (0.00%)  1/274 (0.36%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Benign Lung Neoplasm  0/135 (0.00%)  1/274 (0.36%) 
Hepatic Neoplasm Malignant  0/135 (0.00%)  1/274 (0.36%) 
Lung Adenocarcinoma  0/135 (0.00%)  1/274 (0.36%) 
Nervous system disorders     
Brain Stem Ischaemia  0/135 (0.00%)  1/274 (0.36%) 
Convulsion  1/135 (0.74%)  0/274 (0.00%) 
Optic Neuritis  1/135 (0.74%)  0/274 (0.00%) 
Psychiatric disorders     
Depression  1/135 (0.74%)  2/274 (0.73%) 
Completed Suicide  0/135 (0.00%)  1/274 (0.36%) 
Substance Abuse  1/135 (0.74%)  0/274 (0.00%) 
Suicidal Ideation  0/135 (0.00%)  1/274 (0.36%) 
Suicide Attempt  1/135 (0.74%)  0/274 (0.00%) 
Reproductive system and breast disorders     
Epididymitis  0/135 (0.00%)  1/274 (0.36%) 
Prostatitis  0/135 (0.00%)  1/274 (0.36%) 
Respiratory, thoracic and mediastinal disorders     
Chronic Obstructive Pulmonary Disease  2/135 (1.48%)  0/274 (0.00%) 
Asthma  0/135 (0.00%)  1/274 (0.36%) 
Dyspnoea  0/135 (0.00%)  1/274 (0.36%) 
Haemoptysis  0/135 (0.00%)  1/274 (0.36%) 
Respiratory Failure  0/135 (0.00%)  1/274 (0.36%) 
Vascular disorders     
Orthostatic Hypotension  0/135 (0.00%)  1/274 (0.36%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg
Affected / at Risk (%) Affected / at Risk (%)
Total   132/135 (97.78%)   264/274 (96.35%) 
Blood and lymphatic system disorders     
Anaemia  33/135 (24.44%)  89/274 (32.48%) 
Neutropenia  32/135 (23.70%)  62/274 (22.63%) 
Gastrointestinal disorders     
Nausea  35/135 (25.93%)  69/274 (25.18%) 
Diarrhoea  31/135 (22.96%)  60/274 (21.90%) 
Vomiting  20/135 (14.81%)  25/274 (9.12%) 
Abdominal Pain  8/135 (5.93%)  13/274 (4.74%) 
Dyspepsia  4/135 (2.96%)  17/274 (6.20%) 
Constipation  7/135 (5.19%)  10/274 (3.65%) 
General disorders     
Fatigue  64/135 (47.41%)  129/274 (47.08%) 
Pyrexia  36/135 (26.67%)  63/274 (22.99%) 
Chills  26/135 (19.26%)  44/274 (16.06%) 
Irritability  20/135 (14.81%)  32/274 (11.68%) 
Pain  14/135 (10.37%)  32/274 (11.68%) 
Asthenia  14/135 (10.37%)  29/274 (10.58%) 
Malaise  8/135 (5.93%)  18/274 (6.57%) 
Infections and infestations     
Upper Respiratory Tract Infection  8/135 (5.93%)  27/274 (9.85%) 
Urinary Tract Infection  5/135 (3.70%)  16/274 (5.84%) 
Bronchitis  9/135 (6.67%)  10/274 (3.65%) 
Investigations     
Weight Decreased  21/135 (15.56%)  50/274 (18.25%) 
Metabolism and nutrition disorders     
Decreased Appetite  34/135 (25.19%)  61/274 (22.26%) 
Musculoskeletal and connective tissue disorders     
Myalgia  39/135 (28.89%)  53/274 (19.34%) 
Arthralgia  23/135 (17.04%)  38/274 (13.87%) 
Back Pain  16/135 (11.85%)  19/274 (6.93%) 
Muscle Spasms  8/135 (5.93%)  9/274 (3.28%) 
Nervous system disorders     
Headache  48/135 (35.56%)  93/274 (33.94%) 
Dizziness  17/135 (12.59%)  30/274 (10.95%) 
Psychiatric disorders     
Insomnia  35/135 (25.93%)  78/274 (28.47%) 
Anxiety  16/135 (11.85%)  26/274 (9.49%) 
Depression  30/135 (22.22%)  68/274 (24.82%) 
Respiratory, thoracic and mediastinal disorders     
Cough  10/135 (7.41%)  25/274 (9.12%) 
Dyspnoea  10/135 (7.41%)  25/274 (9.12%) 
Epistaxis  3/135 (2.22%)  14/274 (5.11%) 
Skin and subcutaneous tissue disorders     
Rash  12/135 (8.89%)  26/274 (9.49%) 
Alopecia  9/135 (6.67%)  19/274 (6.93%) 
Dry Skin  9/135 (6.67%)  17/274 (6.20%) 
Pruritus  5/135 (3.70%)  21/274 (7.66%) 
Night Sweats  7/135 (5.19%)  10/274 (3.65%) 
Hyperhidrosis  7/135 (5.19%)  8/274 (2.92%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800-821-8590
Layout table for additonal information
Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00353418     History of Changes
Other Study ID Numbers: NV18209
First Submitted: July 17, 2006
First Posted: July 18, 2006
Results First Submitted: May 14, 2010
Results First Posted: June 15, 2010
Last Update Posted: August 3, 2010