Clinical trial NCT02791256: A Study of Peginterferon Alfa-2a Plus Ribavirin in Early Non-Responder Participants With Chronic Hepatitis C (CHC) Genotype 1, 4, 5, and 6
Official title: An Open-label Pilot Study of Dose Escalation of PEGASYS on Virological Response in Patients With Chronic Hepatitis C Viral Infection Showing an Early Non-response to a Standard Course of PEGASYS Plus Ribavirin
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-06-06
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).


Eligibility criteria: Inclusion Criteria:

* Participants with serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
* Participants had to have been receiving their first treatment for chronic hepatitis C (i.e. previously naive to any therapy) consisting of peginterferon alfa-2a plus ribavirin for 16 weeks (+/- 10 days), without reaching a negative or 2-log drop of Serum Hepatitis C Virus Ribonucleic Acid (HCV-RNA) at Week 12 of therapy as compared to pretreatment value, and must still be on therapy (no wash out)
* HCV-RNA quantifiable by a test reporting in international units
* Compensated liver disease (Child-Pugh Grade A clinical classification)
* Participants with cirrhosis or transition to cirrhosis had to have an abdominal ultrasound, computerized tomography (CT) scan, or magnetic resonance imaging (MRI) scan without evidence of hepatocellular carcinoma and a serum alpha fetoprotein (AFP) less than (\<)100 nanogram pe milliliter (ng/mL) within 6 months of study entry
* Negative urine or blood pregnancy test
* Participants had to be using two forms of effective contraception during treatment and during the 6 months after treatment end
* Able to participate and to comply with the study restrictions

Exclusion Criteria:

* Women with ongoing pregnancy or who are breast feeding and male partners of women who were pregnant
* Neutrophil count \<1,500 cells/cubic millimeter (mm\^3) or platelet count \<90,000 cells/mm\^3 before initiation of the ongoing treatment regimen; or neutrophil count \<750 cells/mm\^3 or platelet count \<50,000 cells/mm\^3 at screening while still on therapy with peginterferon alfa-2a plus ribavirin
* Hemoglobin (Hgb) \<12 gram per deciliter (g/dL) before initiation of the ongoing treatment regimen; or Hgb \<10 g/dL at screening while still on therapy with peginterferon alfa-2a plus ribavirin for at least 12 weeks
* Serum creatinine level greater than (\>)1.5 times the upper limit of normal at screening
* Therapy with any systemic anti-viral, anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) other than the currently failing Pegasys plus ribavirin combination therapy less than or equal to (\<=) 6 months prior to the first dose of study drug
* Positive test for hepatitis A immunoglobulin M (IgM) antibody (anti-HAV IgM Ab), hepatitis B surface antigen (HBsAg), anti-hepatitis B core IgM antibody (anti-HBc IgM Ab), anti-Human Immunodeficiency Virus antibody (anti-HIV Ab)
* History or other evidence of a medical condition associated with chronic liver disease other than HCV
* History of bleeding from esophageal varices or other conditions consistent with decompensated liver disease, severe psychiatric disease (especially depression), severe seizure disorder, thyroid disease, immunologically mediated disease, chronic pulmonary disease, cardiac disease, major organ transplantation or other evidence of severe illness, malignancy
* Evidence of drug abuse including excessive alcohol consumption

Primary outcomes:
measure: Percentage of Participants Achieving Virologic Response, as measured by ultrasensitive Roche HCV TaqMan Test
timeFrame: Week 12
Secondary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response (SVR), as measured by ultrasensitive Roche HCV TaqMan Test
timeFrame: Week 56
measure: Percentage of Participants Achieving End-of-treatment Response, as measured by ultrasensitive Roche HCV TaqMan Test
timeFrame: Week 32
measure: Mean Log Change From Baseline to Week 2, 4, 8, 12, 32, and 56 in Hepatitis C Virus Ribonucleic Acid (HCV-RNA) Viral Load
timeFrame: Baseline, Week 2, 4, 8, 12, 32, 56
measure: Number of Participants With Adverse Events and Serious Adverse
timeFrame: Baseline up to Week 56
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Antwerpen
country: Belgium
city: Brugge
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Bruxelles
country: Belgium
city: Charleroi
country: Belgium
city: Edegem
country: Belgium
city: Gent
country: Belgium
city: Gilly
country: Belgium
city: Haine-saint-paul
country: Belgium
city: Kortrijk
country: Belgium
city: Leuven
country: Belgium
city: Liege
country: Belgium
city: Namur
country: Belgium
city: Roeselare
country: Belgium
city: Yvoir
country: Belgium
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References: