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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02573025




Registration number
NCT02573025
Ethics application status
Date submitted
8/10/2015
Date registered
9/10/2015
Date last updated
13/03/2017

Titles & IDs
Public title
A Bioequivalence Study of Pegylated Interferon Alfa-2a (PEG-IFN Alfa-2a) Benzyl Alcohol (BA)-Free Formulation Versus PEG-IFN Alfa-2a (Pegasys) Following Subcutaneous Administration
Scientific title
An Open-Label, Randomized, Multi-Center, Single Dose, Two-Period, Two Sequence Crossover Study to Investigate the Bioequivalence of Peginterferon (PEG-IFN) Alfa-2a Benzyl Alcohol-Free Formulation Versus the Reference Market Formulation Following Subcutaneous Administration Via Prefilled Syringe in Healthy Chinese Subjects
Secondary ID [1] 0 0
YV29573
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEG-IFN alfa-2a BA-free formulation (Test)
Treatment: Drugs - PEG-IFN alfa-2a market formulation (Reference)

Experimental: Test Followed by Reference - Participants will receive PEG-IFN alfa-2a BA-free formulation (Test) in Period 1, followed by PEG-IFN alfa-2a market formulation (Reference) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days.

Experimental: Reference Followed by Test - Participants will receive PEG-IFN alfa-2a market formulation (Reference) in Period 1, followed by PEG-IFN alfa-2a BA-free formulation (Test) in Period 2 on Day 1 of each period with a washout period of 14 to 21 days.


Treatment: Drugs: PEG-IFN alfa-2a BA-free formulation (Test)
Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).

Treatment: Drugs: PEG-IFN alfa-2a market formulation (Reference)
Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximum Observed Concentration (Cmax) for PEG-IFN alfa-2a
Timepoint [1] 0 0
Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Primary outcome [2] 0 0
Area Under the Concentration-Time Curve (AUC) for PEG-IFN alfa-2a From Time Zero to 816 hours (AUC0-816h)
Timepoint [2] 0 0
Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary outcome [1] 0 0
Area Under the Concentration-Time Curve for PEG-IFN alfa-2a From Time Zero Extrapolated to Infinity (AUC0-inf)
Timepoint [1] 0 0
Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary outcome [2] 0 0
Time to Reach Cmax (tmax) for PEG-IFN alfa-2a
Timepoint [2] 0 0
Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary outcome [3] 0 0
Terminal Half-Life (t1/2) for PEG-IFN alfa-2a
Timepoint [3] 0 0
Predose (-1 Hour), Hour 1, 3, 5, 8, 12, 24, 48, 72, 84, 96, 120, 144, 168, 192, 216, 240, 312, 384, 480, 552, 648, 816 post Dose
Secondary outcome [4] 0 0
Percentage of Participants With Adverse Events
Timepoint [4] 0 0
Baseline up to 35 days post last dose of PEG-IFN alfa-2a (maximum up to 17.5 weeks)

Eligibility
Key inclusion criteria
- Healthy female and male Chinese participants

- Body mass index between 19 and 28 kilograms per square meter (kg/m^2), inclusive

- Participants determined as healthy by their medical history, physical examination,
vital signs, electrocardiogram (ECG), and clinical laboratory measurements performed
at the Screening visit

- Female participants of childbearing potential: willing to use highly effective methods
of contraception throughout the study and for 90 days after the last dosing

- Male participants: agreement to remain abstinent or use spermicide and barrier method
contraception throughout the study and for 90 days after the last dosing

- Able to participate and willing to give written informed consent and to comply with
the study restrictions
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Any clinically relevant condition or history of cardiovascular, psychiatric,
gastrointestinal, respiratory, renal, hepatic, hematological, lymphatic, neurological
(including seizure history), musculoskeletal, genitourinary, immunological, metabolic,
malignant, or dermatological disorder

- Participants who are positive for hepatitis B surface antigen (HBsAg), hepatitis C
virus antibody (anti HCV) or human immunodeficiency virus I and II antibody (anti-HIV
I, anti-HIV II) tests at Screening

- Participants with alanine aminotransferase (ALT) above the upper limit of normal at
Screening or on Day -1 of Period 1

- Any other condition or disease (other than those already stated) which, in the
judgment of the Investigator, would place the participant at undue risk, interfere
with the absorption, distribution, metabolism, and excretion of PEG-IFN alfa-2a, or
interfere with the ability of the participant to complete the study

- History of drug or alcohol abuse within the last year before screening

- Treatment with interferon or PEG-IFN alfa-2a within 3 months prior to the first dosing

- Female participants who are pregnant, currently lactating, or have a positive serum
pregnancy test at screening or have a positive urine pregnancy test on Day -1 of
Period 1

- Use of any prescribed or over the counter medication or herbal medicine taken within
14 days prior to the first dosing or within 5 times the elimination half-life of the
medication prior to the first dosing (whichever is longer). Exceptions are
paracetamol, the contraceptive pill, hormone replacement therapy and commonly used
vitamin supplements, which are permitted

- Regular smoking with consumption of more than 10 cigarettes per day or an equivalent
amount of tobacco

- Participation in an investigational drug or device study within 3 months prior to the
first dosing

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled 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
Crossover
Other design features
Phase
Phase 1
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
17/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
11/04/2016
Sample size
Target
Accrual to date
Final
277
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX A division of IDT Australia Limited - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
Hong Kong
State/province [1] 0 0
Hong Kong
Country [2] 0 0
Hong Kong
State/province [2] 0 0
Shatin
Country [3] 0 0
New Zealand
State/province [3] 0 0
Christchurch
Country [4] 0 0
New Zealand
State/province [4] 0 0
Grafton
Country [5] 0 0
Singapore
State/province [5] 0 0
Singapore
Country [6] 0 0
Taiwan
State/province [6] 0 0
Taichung
Country [7] 0 0
Taiwan
State/province [7] 0 0
Taipei City

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

Ethics approval
Ethics application status

Summary
Brief summary
This is an open-label, randomized, multi-center, single dose, two-period, two-sequence
crossover study to investigate the bioequivalence of PEG-IFN alfa-2a BA-free formulation
versus the reference market formulation (PEG-IFN alfa-2a [Pegasys®]) following subcutaneous
administration via prefilled syringe in healthy Chinese participants.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02573025
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02573025