- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01258101
A Study of PEGASYS (Peginterferon Alfa-2a) Plus Ribavirin in Patients With Chronic Hepatitis C (CHC), Genotype 2 or 3
May 30, 2016 updated by: Hoffmann-La Roche
Randomized, Multicenter Study to Compare the Efficacy of Pegylated Interferon Alfa (PEG-IFN) in Combination With Two Different Doses of Ribavirin in Patients With Chronic Hepatitis C and Subtype 2/3
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily).
The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
395
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Gratwein, Austria, 8112
-
Graz, Austria, 8036
-
Innsbruck, Austria, 6020
-
Linz, Austria, 4020
-
Linz, Austria, 4010
-
Oberndorf, Austria, 5110
-
Ried-innkreis, Austria, 4910
-
Salzburg, Austria, 5020
-
Villach, Austria, 9500
-
Wels, Austria, 4600
-
Wien, Austria, 1030
-
Wien, Austria, 1100
-
Wien, Austria, 1130
-
Wien, Austria, 1160
-
Wien, Austria, 1220
-
Wien, Austria, 1090
-
Wien, Austria, 1140
-
Wiener Neustadt, Austria, 2700
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients, 18-65 years of age
- Chronic hepatitis C, genotype 2 or 3
- Positive HCV RNA level in serum at screening (COBAS AMPLICOR MONITOR HCV test)
- Abdominal sonography within 3 months prior to study start
Exclusion Criteria:
- Previous interferon and/or pegylated interferon and ribavirin therapy
- Liver cirrhosis, class B or C (Child-Pugh)
- Systemic anti-neoplastic or immunomodulatory treatment <=6 months before study drug
- History or evidence of medical condition associated with chronic liver disease other than chronic hepatitis C
- Decompensated liver disease
- Positive for HIV
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Peginterferon/Ribavirin 800 mg (24 Weeks)
Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W).
|
180 mcg sc weekly, 24 weeks
180 mcg sc weekly, 16 weeks
800 mg orally daily
400 mg orally daily
|
Experimental: Peginterferon/Ribavirin 400 mg (24 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W.
|
180 mcg sc weekly, 24 weeks
180 mcg sc weekly, 16 weeks
800 mg orally daily
400 mg orally daily
|
Experimental: Peginterferon/Ribavirin 800 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W.
|
180 mcg sc weekly, 24 weeks
180 mcg sc weekly, 16 weeks
800 mg orally daily
400 mg orally daily
|
Experimental: Peginterferon/Ribavirin 400 mg (16 Weeks)
Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.
|
180 mcg sc weekly, 24 weeks
180 mcg sc weekly, 16 weeks
800 mg orally daily
400 mg orally daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Who Achieve Sustained Virologic Response Rate At 24 Weeks Post Completion of the Treatment
Time Frame: Up to Week 48 (24 weeks post completion of the treatment)
|
Sustained virological response was defined as the percentage of participants in each group with undetectable Hepatitis C virus-Ribonucleic acid (HCV-RNA) measurement at 24 weeks post completion of the treatment.
|
Up to Week 48 (24 weeks post completion of the treatment)
|
Percentage of Participants With Hepatitis C Virus-RNA Determined by AMPLICOR HCV Test At Week 24 and Week 48
Time Frame: At Week 24 and Week 48
|
Serum Hepatitis C Virus-RNA (HCV-RNA) was done by Polymerase chain reaction (PCR).
Samples for a qualitative PCR (AMPLICOR® HCV Test v2.0) were obtained at Week 24 and Week 48.
'G2' and 'G3' indicates Genotype 2 and Genotype 3 respectively.
|
At Week 24 and Week 48
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Virological Response at the End of the Treatment
Time Frame: At Week 16 and Week 24
|
Virological response at the end of the treatment (ETR) was defined as the percentage of participants with negative qualitative PCR in each group at completion of the treatment.
ETR is defined as Week 16 and Week 24.
|
At Week 16 and Week 24
|
Percentage of Participants With Virologic Response Rates as Per Genotype at End of Treatment
Time Frame: At Week 16 and Week 24
|
Virologic Response was defined as undetectable HCV-RNA levels (determined by AMPLICOR HCV test) at Week 16 and Week 24.
Virologic response rates based on genotype (G2 and G3) were reported.
ETR is defined as Week 16 and Week 24.
|
At Week 16 and Week 24
|
Number of Participants With Any Adverse Events and Any Serious Adverse Events
Time Frame: Up to Week 48
|
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started.
An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug.
A Serious adverse event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect.
|
Up to Week 48
|
Median Hemoglobin Levels at End of Treatment
Time Frame: At Week 16 and Week 24
|
Hemoglobin (Hb) levels at end of treatment (Week 16 and Week 24) were reported.
The mean lowest Hb value after treatment starts with a median of 129 gram (g)/Litre (L).
The far most frequent hemoglobin class was >=100 g/L.
The purpose of assessing the Hb levels is associated with ribavirin dose.
The primary toxicity of ribavirin dose (1000-1200 mg/day, maximum tolerated dose) is anemia with a reduction in hemoglobin levels generally occurring within the first 1-2 weeks of initiating therapy.
Decreases in hemoglobin seen in the combination treatment of ribavirin and Interferon-alfa are managed with reduction in ribavirin dosage to 600 mg/day.
|
At Week 16 and Week 24
|
Mean SF-36 Scores at Baseline and Weeks 16, 24 and 48
Time Frame: At Baseline (Week 0) and Weeks 16, 24 and 48
|
Short-Form Health Survey (SF-36) is a 36-item questionnaire measuring eight domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health).
Each domain score ranges from 0 (worst) to 100 (best), with higher scores reflecting better health-related functional status.
Where Baseline (BS) is Week 0.
|
At Baseline (Week 0) and Weeks 16, 24 and 48
|
Mean FSS Scores at Baseline and Weeks 16, 24 and 48
Time Frame: At Baseline (Week 0) and Weeks 16, 24 and 48
|
The Fatigue Severity Scale (FSS) is a self-administered instrument that includes 9 items rated on a 7-point scale, measuring fatigue severity.
The participants were asked to score each statement, based on how the statement applied to them over the preceding week.
The fatigue severity score is the average of the scores on the 9 questions; scores range from 1-7, with lower scores indicating less fatigue.
Baseline is defined as Week 0.
|
At Baseline (Week 0) and Weeks 16, 24 and 48
|
Mean Beschwerdeliste Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 16, 24 and 48
Time Frame: At Baseline (Week 0) and Weeks 16, 24 and 48
|
Psychiatric assessment were performed using Beschwerdeliste (BL) questionnaires.
BL results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status.
The BL questionnaire items were scored by calculating the average response to all answered items.
Items were graded 1="stark" (affliction is strong) to 4="gar nicht" (not present).
The higher the BL score, the less afflictions were present for a participant.
Baseline is defined as Week 0.
|
At Baseline (Week 0) and Weeks 16, 24 and 48
|
Beck Depression Inventory Mean Score for Participants Receiving an Opioid Maintenance Therapy At Baseline and Weeks 4, 8, 12, 24 and 48
Time Frame: At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48
|
For the psychiatric assessment, the results of the Beck Depression Inventory (BDI) questionnaires were evaluated.
BDI results were analyzed descriptively by visit, treatment group, genotype and opioid maintenance therapy status.
BDI is 21 item participant rated inventory evaluates depression symptoms, cognition, and physical symptoms of fatigue, weight loss, lack of interest in sex.
Individual items are scored on a 4 point scale (0 to 3), with 0=none/absent and 3=most severe.
Total score: 0 to 63; higher score indicates more depression.
Mean scores are presented by visit.
Baseline is defined as Week 0.
|
At Baseline (Week 0) and Weeks 4, 8, 12, 24 and 48
|
Time to Viral Response
Time Frame: Up to Week 48
|
Time to viral response was calculated as Date of first negative PCR result after screening - date of PCR screening sample + 1 [in days].
Mean of number of days to viral response for overall population were reported.
|
Up to Week 48
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
July 1, 2008
Study Registration Dates
First Submitted
November 29, 2010
First Submitted That Met QC Criteria
December 9, 2010
First Posted (Estimate)
December 10, 2010
Study Record Updates
Last Update Posted (Estimate)
July 11, 2016
Last Update Submitted That Met QC Criteria
May 30, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis, Chronic
- Hepatitis
- Hepatitis A
- Hepatitis C
- Hepatitis C, Chronic
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites
- Immunologic Factors
- Interferon-alpha
- Ribavirin
- Peginterferon alfa-2a
Other Study ID Numbers
- ML17087
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C, Chronic
-
Sohag UniversityRecruiting
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hospices Civils de LyonCompleted
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
Humanity and Health Research CentreBeijing 302 Hospital; Nanfang Hospital of Southern Medical University; Yamanashi...Recruiting
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
Sunshine Lake Pharma Co., Ltd.CompletedChronic Hepatitis cChina
Clinical Trials on peginterferon alfa-2a [Pegasys]
-
Hoffmann-La RocheCompletedHepatitis C, ChronicRussian Federation
-
Hoffmann-La RocheCompletedHepatitis B, ChronicRussian Federation
-
Hoffmann-La RocheCompletedHepatitis B, ChronicTaiwan, United States, New Zealand, Singapore
-
The Catholic University of KoreaUlsan University Hospital; Yonsei University; Kyungpook National University Hospital and other collaboratorsCompletedSustained Virologic Response | IL28B PolymorphismKorea, Republic of
-
Hoffmann-La RocheCompletedHepatitis B, ChronicChina, Hong Kong, Australia, Germany, Taiwan, Singapore, France, United States, Korea, Republic of, New Zealand, Thailand, Russian Federation, Brazil
-
Hoffmann-La RocheTerminated
-
Hoffmann-La RocheCompleted
-
Hoffmann-La RocheCompleted
-
Hoffmann-La RocheCompletedHepatitis B, ChronicChina, Hong Kong, Taiwan, Singapore, Korea, Republic of, New Zealand, Thailand, Brazil, Russian Federation, Australia