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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02864199




Registration number
NCT02864199
Ethics application status
Date submitted
9/08/2016
Date registered
11/08/2016
Date last updated
11/08/2016

Titles & IDs
Public title
A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment
Scientific title
Non-Randomized, Multicenter Study to Evaluate the Pharmacokinetics and Safety of Peginterferon Alfa-2a and Copegus Combination Therapy After Single and Multiple Doses in Patients With Chronic Hepatitis C and Moderate Renal Impairment, Severe Renal Impairment, or End-Stage Renal Disease Undergoing Hemodialysis
Secondary ID [1] 0 0
NP17355
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Renal and Urogenital 0 0 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Peginterferon alfa-2a
Treatment: Drugs - Ribavirin

Experimental: Group A: Moderate Renal Impairment - Participants with CrCl 30 to 50 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 micrograms (mcg) via subcutaneous (SC) injection once weekly, in combination with ribavirin, 600 milligrams (mg) orally (PO) daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.

Experimental: Group B: Severe Renal Impairment - Participants with CrCl <30 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 400 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.

Experimental: Group C: Hemodialysis/ESRD - Participants requiring hemodialysis will receive 12 weeks of peginterferon alfa-2a, 135 mcg via SC injection once weekly, in combination with ribavirin, 200 mg PO every morning. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.

Experimental: Group D: Normal Renal Function - Participants with CrCl >80 mL/min will receive 12 weeks of peginterferon alfa-2a, 180 mcg via SC injection once weekly, in combination with ribavirin, 800 to 1200 mg PO daily in two divided doses. Those with Genotype 2 or 3 disease may receive an additional 12 weeks of the same regimen, and those with another genotype may receive an additional 36 weeks.


Treatment: Drugs: Peginterferon alfa-2a
Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.

Treatment: Drugs: Ribavirin
Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cmax of peginterferon alfa-2a
Timepoint [1] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Primary outcome [2] 0 0
CL/F of ribavirin
Timepoint [2] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Primary outcome [3] 0 0
Percentage of participants with undetectable HCV RNA level
Timepoint [3] 0 0
Week 12
Primary outcome [4] 0 0
Cmax of ribavirin
Timepoint [4] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Primary outcome [5] 0 0
AUC of ribavirin
Timepoint [5] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Primary outcome [6] 0 0
AUC of peginterferon alfa-2a
Timepoint [6] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Primary outcome [7] 0 0
Clearance (CL/F) of peginterferon alfa-2a
Timepoint [7] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Secondary outcome [1] 0 0
Time of maximum concentration (Tmax) of peginterferon alfa-2a
Timepoint [1] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Secondary outcome [2] 0 0
Tmax of ribavirin
Timepoint [2] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Secondary outcome [3] 0 0
Plasma concentration of ribavirin
Timepoint [3] 0 0
Pre-dose (0 hours) and 0.5, 1, 3, 5, 8, 12, 24, 72, 120, and 168 hours post-dose during Weeks 1 and 12
Secondary outcome [4] 0 0
Percentage of participants with adverse events (AEs)
Timepoint [4] 0 0
From Baseline to Week 12 (or up to Week 48 if treatment continued)
Secondary outcome [5] 0 0
Percentage of participants with a dose modification or premature withdrawal for safety reasons
Timepoint [5] 0 0
From Baseline to Week 12 (or up to Week 48 if treatment continued)

Eligibility
Key inclusion criteria
- Adults 18 to 65 years of age

- CHC infection as shown on enzyme-linked immunosorbent assay (ELISA) and
radioimmunoblot assay (RIBA) or quantifiable hepatitis C virus (HCV) ribonucleic acid
(RNA) greater than (>) 2000 copies per milliliter (copies/mL)

- Use of two forms of contraception during study and 6 months after the study in both
men and women

- Normal renal function (creatinine clearance [CrCl] >80 milliliters per minute
[mL/min]), moderate renal impairment (CrCl 30 to 50 mL/min), severe renal impairment
(CrCl less than [<] 30 mL/min), or ESRD requiring hemodialysis

- Patients with ESRD must have been undergoing hemodialysis for at least 2 months
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are pregnant or breastfeeding

- Male partners of women who are pregnant

- Conditions associated with decompensated and/or chronic liver disease

- Human immunodeficiency virus (HIV) infection

- Interferon or ribavirin treatment within the previous 3 months

- Poor hematologic function, including unstable hemoglobin

- Significant comorbidity or severe illness which would make the participant unsuitable
for the study

- Acute renal failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Kansas
Country [3] 0 0
United States of America
State/province [3] 0 0
Louisiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Missouri
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Oregon
Country [8] 0 0
United States of America
State/province [8] 0 0
Pennsylvania
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Brazil
State/province [10] 0 0
Sao Paulo
Country [11] 0 0
France
State/province [11] 0 0
Marseille
Country [12] 0 0
New Zealand
State/province [12] 0 0
Christchurch
Country [13] 0 0
New Zealand
State/province [13] 0 0
Riccarton, Christchurch
Country [14] 0 0
Sweden
State/province [14] 0 0
Huddinge

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum
concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and
ribavirin combination therapy following single and multiple doses in participants with CHC
infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving
hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target
sample size is 48 individuals.
Trial website
https://clinicaltrials.gov/show/NCT02864199
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications