Trial Outcomes & Findings for A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials (NCT NCT01853254)
NCT ID: NCT01853254
Last Updated: 2013-09-04
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
272 participants
Primary outcome timeframe
From Baseline to the end of the study (up to 72 weeks)
Results posted on
2013-09-04
Participant Flow
Participant milestones
| Measure |
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
|
|---|---|
|
Overall Study
STARTED
|
272
|
|
Overall Study
COMPLETED
|
168
|
|
Overall Study
NOT COMPLETED
|
104
|
Reasons for withdrawal
| Measure |
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
|
|---|---|
|
Overall Study
Abnormal Laboratory Test
|
1
|
|
Overall Study
Adverse Event/Intercurrent Illness
|
3
|
|
Overall Study
Death
|
1
|
|
Overall Study
Failure to Return
|
43
|
|
Overall Study
Insufficient Therapeutic Response
|
22
|
|
Overall Study
Refusal of Treatment
|
1
|
|
Overall Study
Other Protocol Violation
|
1
|
|
Overall Study
Withdrawal of Consent
|
16
|
|
Overall Study
Administrative/Other
|
16
|
Baseline Characteristics
A Study of Pegasys (Peginterferon Alfa-2a) Administered Alone or in Combination With Copegus (Ribavirin) in Patients With Chronic Hepatitis C Who Have Participated in Previous Pegasys Trials
Baseline characteristics by cohort
| Measure |
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin
n=272 Participants
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
|
|---|---|
|
Age Continuous
|
48.3 years
STANDARD_DEVIATION 9.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
90 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
182 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
189 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Oriental
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
53 Participants
n=5 Participants
|
|
Height
|
172.4 Centimeters (cm)
STANDARD_DEVIATION 10.22 • n=5 Participants
|
|
Weight
|
85.72 Kilograms (kg)
STANDARD_DEVIATION 19.803 • n=5 Participants
|
|
Body Mass Index (BMI)
|
28.8 kg/m^2
STANDARD_DEVIATION 5.89 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Baseline to the end of the study (up to 72 weeks)Population: All participants analysis set.
Outcome measures
| Measure |
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin
n=272 Participants
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
|
|---|---|
|
Percentage of Participants With at Least 1 Adverse Event
|
38.2 Percentage of participants
|
Adverse Events
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin
Serious events: 17 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin
n=272 participants at risk
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.74%
2/272
All participants analysis set.
|
|
Cardiac disorders
Angina pectoris
|
0.37%
1/272
All participants analysis set.
|
|
Cardiac disorders
Palpitations
|
0.37%
1/272
All participants analysis set.
|
|
Eye disorders
Amaurosis fugax
|
0.37%
1/272
All participants analysis set.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.37%
1/272
All participants analysis set.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.37%
1/272
All participants analysis set.
|
|
Infections and infestations
Cellulitis
|
0.37%
1/272
All participants analysis set.
|
|
Infections and infestations
Cryptosporidiosis infection
|
0.37%
1/272
All participants analysis set.
|
|
Infections and infestations
Gastroenteritis
|
0.37%
1/272
All participants analysis set.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.37%
1/272
All participants analysis set.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.37%
1/272
All participants analysis set.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.37%
1/272
All participants analysis set.
|
|
Investigations
Antibiotic resistant Staphylococcus test positive
|
0.37%
1/272
All participants analysis set.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.37%
1/272
All participants analysis set.
|
|
Nervous system disorders
Loss of consciousness
|
0.37%
1/272
All participants analysis set.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.37%
1/272
All participants analysis set.
|
|
Psychiatric disorders
Depression
|
0.37%
1/272
All participants analysis set.
|
|
Renal and urinary disorders
Renal failure acute
|
0.37%
1/272
All participants analysis set.
|
Other adverse events
| Measure |
Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin
n=272 participants at risk
The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.7%
21/272
All participants analysis set.
|
|
Blood and lymphatic system disorders
Neutropenia
|
8.1%
22/272
All participants analysis set.
|
Additional Information
Medical Communications
Hoffmann-La Roche
Phone: 800 821-8590
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER