Hepatitis C, ChronicPhase 4NCT02641379

A Study of Peginterferon Alfa-2a (Pegasys) When Administered in Combination With Ribavirin in Patients With Chronic Hepatitis C (CHC)

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 21 sites in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will compare the efficacy and safety of 2 different treatment durations of peginterferon alfa-2a (Pegasys) plus ribavirin in patients with CHC. The anticipated time on study treatment is 1-2 years, and the target sample size is greater than (>) 500 individuals. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C, Chronic
What is being tested?: Peginterferon alfa-2a and Ribavirin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 737 participants
Where: 21 sitesAustria
Study dates: May 2003to Nov 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male and female patients with chronic hepatitis C and genotype 1 (1a or 1b) or genotype 4
Age between 18 and 70 years
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Present with at least one elevated serum alanine-aminotransferase (ALT) level higher than normal in the last 6 months before therapy start including the screening period
Positive HCV-RNA level in serum
Laboratory parameters (within 35 days prior to study start): -Hepatitis A anti - IgM negativity, HIV-Ab negativity, HBsAg negativity, Hemoglobin values > 12 g/dl in women or > 13 g/dl in men, Leukocyte count (WBC) > 3 000 /mcl, Platelets count > 100 000/mcl, Creatinine not 1.5 times higher than normal, normal TSH, normal uric acid with a maximum tolerance of 15 % in patients without history of gout

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Liver biopsy findings within 6 months prior to study therapy consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis. Biopsies older than 1 year are eligible only after direct communication with the principal investigator
Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug. If there is no laboratory report existing, the physician should make an entry in the medical history that the pregnancy test was negative.
All fertile females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end. All fertile men with female partners must be using two forms of effective contraception during treatment and during the 7 months after treatment end.
Written informed consent obtained

Who cannot join

Any IFN and / or Pegylated IFN and ribavirin therapy at any previous time
Class B or C cirrhosis as coded by Child Pugh classification
Women with ongoing pregnancy or breast feeding
Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
Any investigational drug 6 weeks prior to the first dose of study drug
Drug addiction within 1 year prior to study start (patients participating in an official methadone program are eligible)

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Diabetes mellitus in patients receiving an insulin therapy
Hemophiliac patients (due to the increased risk of requested liver biopsy)
History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease. Exception: if there is a current psychiatric report which certifies there is no contraindication to interferon therapy, patient may be included
History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, rheumatoid arthritis etc.)
History or other evidence of chronic pulmonary disease associated with functional limitation
History of a severe seizure disorder or current anticonvulsant use
History of severe cardiac disease and severe coronary heart disease within the last 6 months (angina pectoris, congestive heart failure, recent myocardial infarction, severe hypertension or significant arrhythmia). If there is clinical suspicion of coronary heart disease cardiologic workup of the patient prior to study entry is recommended.
History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
History of major organ transplantation with an existing functional graft
Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
Inability or unwillingness to provide informed consent or abide by the requirements of the study
Additional exclusion criteria concerning ribavirin:
Male partners of women who are pregnant
Any patient with an increased baseline risk for anemia (e.g. thalassemia, spherocytosis, history of GI bleeding, etc) or for whom anemia would be medically problematic
Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL would not be well-tolerated

Trial locations and contacts

21 sites in 1 country.

City, postcode or hospital

21 sites in 1 country

Austria21 sites

Study site
Feldkirch, 6800
Study site
Gratwein, 8112
Study site
Graz, 8020
Study site
Graz, 8036
Study site
Innsbruck, 6020
Study site
Krems, 3500
Study site
Linz, 4010
Study site
Linz, 4020
Study site
Oberndorf, 5110
Study site
Oberpullendorf, 7350
Study site
Ried-innkreis, 4910
Study site
Salzburg, 5020
Study site
Vienna, 1030
Study site
Vienna, 1090
Study site
Vienna, 1100
Study site
Vienna, 1130
Study site
Vienna, 1140
Study site
Vienna, 1160
Study site
Villach, 9500
Study site
Wels, 4600
Study site
Wiener Neustadt, 2700

Other trials in Austria

About this study

Official title: Randomized, Multicenter Study to Find Optimal Treatment Duration in Patients With Chronic Hepatitis C and Subtype 1 or 4 Depending on HCV RNA Level at Week 8 and Week 12

Conditions: Hepatitis C, Chronic
Being tested: Peginterferon alfa-2a, Ribavirin
Medical subject headings: Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peginterferon alfa-2aDrug
Also called Pegasys
PEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\n
RibavirinDrug
Ribavirin is available as 200 mg tablets

Study groups in NCT02641379
Study group	Role	What they receive
PEG-IFN 24 weeks	Experimental	Participants will receive PEG-IFN (180 microgram [mcg]), subcutaneously (sc), once weekly for 24 weeks and Ribavirin 1000-1200 milligram per day (mg/day) (<75 kilogram (kg); >75 kg) for 24 weeks. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
PEG-IFN 24/72 weeks	Experimental	Participants will receive PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) till week 24; if patient is still HCV RNA positive. Treatment will be stopped if participant is HCV RNA negative at week 24 -treatment with PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) till week 72 Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
PEG-IFN 48 weeks	Experimental	Participants will receive PEG-IFN (180 mcg), sc, once weekly for 48 weeks and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) for 48 weeks. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin
PEG-IFN 72 weeks	Experimental	Participants will receive PEG-IFN (180 mcg), sc, once weekly for 72 weeks and Ribavirin 1000-1200 mg/day (<75 kg; > 75 kg) for 72 weeks. Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.
Measured: Up to Week 96
Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.
Measured: Up to Week 96

Secondary outcomes (13)

Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)
End of treatment response (ETR) rate was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV negative at Week 24 of Group D, Week 48 of Group A and at Week 72 of Groups B and C). Participants without a HCV RNA results at this time point were considered as non-responders. End of the treatment period was defined as Week 48 for Group A, Week 72 for Groups B and C, and Week 24 for Group D.
Measured: Up to Week 72
Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)
The SVR was defined as the percentage of participants in each group with a non-detectable HCV RNA result at 24 weeks post-completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D, at Week 72 of Group A, and at Week 96 of Groups B and C). Participants without a HCV RNA PCR at this time point were considered as non-responders in this calculation. The end of follow-up was defined as Week 72 for Group A, Week 96 for Groups B and C, and Week 48 for Group D.
Measured: Up to Week 96
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
The Short Form-36 (SF-36) is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual and Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores are presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A and B) and at Week 96 (for Group B). Lower score indicate worsening.
Measured: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
The Fatigue Severity Scale (FSS) is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A and B) and at Week 96 (for Group B).
Measured: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Liver fibrosis stage was scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline is presented.
Measured: Baseline (Day 1)
Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
An adverse event (AE) is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. 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.
Measured: Up to Week 96
Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)
Virological relapse rate was defined as percentage of participants with non-detectable HCV RNA (< 15 IU/ml) at the EoT and detectable HCV RNA (≥ 15 IU/ml) at the end of FU. The end of treatment was defined as Week 48 in Group A1 and Week 72 in Group B1 and the end of follow-up was defined as Week 72 in Group A1 and Week 96 in Group B1.
Measured: Up to Week 96
Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)
ETR virological response rate at the end of treatment period was defined as the percentage of participants in each group with non-detectable HCV RNA at completion of the treatment period (HCV RNA quantitative PCR result < 15 IU/ml at Week 24 for Group D, at Week 48 for Group A1, at Week 72 for Groups B1 and C). Participants without a HCV RNA PCR (missing values) at this time point were considered as non-responders in this calculation. The end of treatment period was defined as Week 48 for Group A1, Week 72 for Groups B1 and C1, and Week 24 for Group D.
Measured: Up to Week 72
Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)
The SVR was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 48 of Group D and at Week 96 of Group C). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 96 for Group C and Week 48 for Group D.
Measured: Up to Week 96
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
The SF-36 is a quality of life instrument consisting of a 36-item questionnaire. The SF-36 items were scored and transformed according to the SF-36 Health Survey Manual \& Interpretation Guide. Summary scores for SF-36 dimensions (physical functioning, role functioning, bodily pain, general health, vitality, social functioning, mental health, health transition) as well as physical and mental summary measures were compiled after imputation of mean scores for missing items if more than 50% of dimension-related items were available. Scores for health transition ranged from 0 (worst) to 5 (best). Scores for all other dimensions ranged from 0 (worst) to 100 (best). The mean SF-36 scores were presented at Baseline (Day 1), Week 24, Week 48, Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C). Lower score indicate worsening.
Measured: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
The FSS is an instrument consisting of 10 self-administered questions. The FSS items were scored by calculating the average response to all answered items (including the 9 questions and the fatigue symptoms). Each of the 9 questions had answers within a score range of 1-7. A score of 1 for any question indicates less fatigue in everyday life and a score of 7 indicates a higher likelihood of fatigue in everyday life. The mean FSS scores are presented at Baseline (Day 1), Week 24, Week 48 and Week 72 (for Groups A1, B1 and C) and at Week 96 (for Groups B1 and C).
Measured: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Liver fibrosis stage was based upon biopsy and scored using the METAVIR system (Grade 0 to 4). Grade 0 indicates no fibrosis, Grade 1 indicates stellate enlargement of portal tract but without septa formation, Grade 2 indicates enlargement of portal tract with rare septa formation, Grade 3 indicates numerous septa without cirrhosis and grade 4 indicates cirrhosis. The number of participants with fibrosis grades ranging from 0 to 4 at Baseline (Day 1) is presented.
Measured: Baseline (Day 1)
Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A 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.
Measured: Up to Week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2003Nov 2013

First posted29 Dec 2015 (estimated)
Study startMay 2003
Primary completionNov 2013
Study completionNov 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hepatitis C, ChronicStudies of the same condition, open and under way.
More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 737 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02641379
Sponsor's protocol ID: ML17131
Status last verified: Jun 2016
First submitted: 11 Dec 2015
Last updated: 4 Aug 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 4
People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents
Diabetes Mellitus, Hepatitis C, Chronic
RecruitingObservational study
"Constitution of a Biological Collection to Establish Preclinical Translational Models for the Study of Tumors and Chronic Liver Diseases".
Chronic Liver Disease and Cirrhosis, Liver Cancer
Active, not recruitingPhase 4
Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy
Hepatitis C, Chronic, Pregnancy; Infection
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic

All Hepatitis C, Chronic trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Multicenter Study to Find Optimal Treatment Duration in Patients With Chronic Hepatitis C and Subtype 1 or 4 Depending on HCV RNA Level at Week 8 and Week 12
ClinicalTrials.gov ID: NCT02641379
Acronym / sponsor ID: ML17131
Conditions: Hepatitis C, Chronic
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 737 participants (actual)
Lead sponsor: Hoffmann-La RocheIndustry (pharma, biotech, devices)
Study start: May 2003
Primary completion: Nov 2013 (actual)
Study completion: Nov 2013 (actual)
First posted: 29 Dec 2015 (estimated)
Results: Posted 4 Aug 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
PEG-IFN 24 weeks	Experimental	Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants will receive PEG-IFN (180 microgram [mcg]), subcutaneously (sc), once weekly for 24 weeks and Ribavirin 1000-1200 milligram per day (mg/day) (<75 kilogram (kg); >75 kg) for 24 weeks.
PEG-IFN 24/72 weeks	Experimental	Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants will receive PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) till week 24; if patient is still HCV RNA positive. Treatment will be stopped if participant is HCV RNA negative at week 24 -treatment with PEG-IFN (180 mcg), sc, once weekly and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) till week 72
PEG-IFN 48 weeks	Experimental	Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants will receive PEG-IFN (180 mcg), sc, once weekly for 48 weeks and Ribavirin 1000-1200 mg/day (<75kg; >75 kg) for 48 weeks.
PEG-IFN 72 weeks	Experimental	Drug: Peginterferon alfa-2a, Drug: RibavirinParticipants will receive PEG-IFN (180 mcg), sc, once weekly for 72 weeks and Ribavirin 1000-1200 mg/day (<75 kg; > 75 kg) for 72 weeks.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Male and female patients with chronic hepatitis C and genotype 1 (1a or 1b) or genotype 4
Age between 18 and 70 years
Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
Present with at least one elevated serum alanine-aminotransferase (ALT) level higher than normal in the last 6 months before therapy start including the screening period
Positive HCV-RNA level in serum

Key exclusion criteria (24 listed)

Any IFN and / or Pegylated IFN and ribavirin therapy at any previous time
Class B or C cirrhosis as coded by Child Pugh classification
Women with ongoing pregnancy or breast feeding
Therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 6 months prior to the first dose of study drug
Any investigational drug 6 weeks prior to the first dose of study drug

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peginterferon alfa-2aAlso: PegasysPEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\n	Drug	PEG-IFN 24 weeks, PEG-IFN 24/72 weeks, PEG-IFN 48 weeks, PEG-IFN 72 weeks
RibavirinRibavirin is available as 200 mg tablets	Drug	PEG-IFN 24 weeks, PEG-IFN 24/72 weeks, PEG-IFN 48 weeks, PEG-IFN 72 weeks

Primary outcome

Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)
Time frame: Up to Week 96
Relapse rate (RR) was defined as the percentage of participants with non-detectable HCV RNA (< 100 copies/ml) at the end of treatment and detectable HCV RNA at the end of follow-up. End of treatment was defined as Week 48 for Group A and Week 72 for Group B, respectively. The end of follow-up was defined as Week 72 for Group A and Week 96 for Group B, respectively. Relapse rate for treatment Groups A and B, stratified for genotype (Genotype I and Genotype IV) and Week 4 response (< 600 units/milliliter [U/ml] and >= 600 U/ml) is presented.
Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)
Time frame: Up to Week 96
The Sustained Virological Response (SVR) was defined as the percentage of participants in each group with non-detectable HCV RNA result at 24 weeks post completion of the treatment period (HCV RNA < 15 IU/ml at Week 72 of Groups A1 and E, and at Week 96 of Group B1). Participants without a HCV RNA results at this time point were considered as non-responders. The end of follow-up was defined as Week 72 for Groups A1 and E, and Week 96 for Group B1. The SVR for treatment Groups A1 + B1 and E, stratified for genotype (Genotype I and Genotype IV) is presented.

13 secondary outcomes

Percentage of Participants With Virological Response Rate in Groups A, B, C, and D at the End of Treatment Period (Part 1)
Time frame: Up to Week 72
Percentage of Participants Achieving Sustained Virological Response in Groups A, B, C, and D at the End of Follow-up (Part 1)
Time frame: Up to Week 96
Mean Short Form-36 Questionnaire Scores for Groups A and B Over Time (Part 1)
Time frame: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96
Mean Fatigue Severity Scale Scores for Groups A and B Over Time (Part 1)
Time frame: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 1)
Time frame: Baseline (Day 1)
Number of Participants With Adverse Events and Serious Adverse Events (Part 1)
Time frame: Up to Week 96
Percentage of Participants With Relapse Rates in Groups A1 and B1 at the End of Follow-up (Part 2)
Time frame: Up to Week 96
Percentage of Participants With Virological Response Rates in Group A1, B1, C and D at the End of the Treatment Period (Part 2)
Time frame: Up to Week 72
Percentage of Participants Achieving Sustained Virological Response in Groups C and D by Genotype at the End of Follow-up (Part 2)
Time frame: Up to Week 96
Mean Short Form-36 Questionnaire Scores for Groups A1, B1, and C Over Time (Part 2)
Time frame: Baseline (Day 1), Week 24, Week 48, Week 72, and Week 96
Mean Fatigue Severity Scale Scores for Groups A1, B1 and C Over Time (Part 2)
Time frame: Baseline (Day 1), Week 24, Week 48 and Week 72, and Week 96
Number of Participants With Fibrosis Grades 0 to 4 at Baseline (Part 2)
Time frame: Baseline (Day 1)
Number of Participants With Adverse Events and Serious Adverse Events (Part 2)
Time frame: Up to Week 96

Results and safety

Results posted to the registry on 4 Aug 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)	142	107
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)	152	101
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)	78	7
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)	156	139
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)	17	0
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)	36	20
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)	25	12
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)	20	1
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)	42	36
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)	45	36
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)	8	0

Primary outcome: Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1)

Time frame: Up to Week 96. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) n = 142	PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1) n = 152
Genotype I, Week 4 response < 600 U/ml,n= 130, 136	22.0 (10.6 to 37.6)	8.3 (1.8 to 22.5)
Genotype I,Week 4 response >=600 U/ml, n =130, 136	52.7 (38.8 to 66.3)	30.0 (17.9 to 44.6)
Genotype IV, Week 4 response < 600 U/ml, n =12, 16	0.0 (0.0 to 52.2)	42.9 (9.9 to 81.6)
Genotype IV, Week 4 response >=600 U/ml, n =12, 16	80.0 (28.4 to 99.5)	80.0 (28.4 to 99.5)

PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) vs PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1): p = 0.1002, Chi-squared
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) vs PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1): p = 0.0184, Chi-squared
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1) vs PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1): p = 0.0910, Chi-squared

Population analysed: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = number of participants analyzed according to genotype and Week 4 response.

Primary outcome: Percentage of Participants Achieving Sustained Virological Response in Groups A1, B1, and E by Genotype at the End of Follow-up (Part 2)

Time frame: Up to Week 96. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2) n = 33	PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2) n = 23	PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2) n = 45
Genotype I, n = 33, 23, 39	30.3 (15.6 to 48.7)	34.8 (16.4 to 57.3)	64.1 (47.2 to 78.8)
Genotype IV, n = 3, 2, 6	33.3 (0.8 to 90.6)	0.0 (0.0 to 84.2)	50.0 (11.8 to 88.2)

PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2) vs PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2) vs PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2): p = 0.0021, Cochran-Mantel-Haenszel
PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2) vs PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2) vs PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2): p = 0.3031, Cochran-Mantel-Haenszel

Population analysed: The ITT population included all participants randomized and allocated to receive treatments. Here, 'n' = the number of participants analyzed according to genotype.

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to Week 96. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)	22 of 142 (15.5%)	139 of 142 (97.9%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)	28 of 152 (18.4%)	147 of 152 (96.7%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)	8 of 78 (10.3%)	76 of 78 (97.4%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)	14 of 156 (9%)	150 of 156 (96.2%)	Not reported
PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)	2 of 12 (16.7%)	9 of 12 (75%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)	1 of 36 (2.8%)	36 of 36 (100%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)	3 of 25 (12%)	25 of 25 (100%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)	2 of 20 (10%)	19 of 20 (95%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)	5 of 42 (11.9%)	40 of 42 (95.2%)	Not reported
PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)	7 of 45 (15.6%)	42 of 45 (93.3%)	Not reported
PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)	1 of 8 (12.5%)	6 of 8 (75%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Trials study chair

Hoffmann-La Roche

21 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Peginterferon alfa-2a and Ribavirin in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 21 sites in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Relapse Rate in Groups A and B by Genotype at the End of Follow-up (Part 1) (time frame: Up to Week 96). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02641379.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.