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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01001754




Registration number
NCT01001754
Ethics application status
Date submitted
23/10/2009
Date registered
27/10/2009
Date last updated
5/12/2011

Titles & IDs
Public title
Efficacy and Safety Study of PEG-rIL-29 Plus Ribavirin to Treat Chronic Hepatitis C Virus Infection
Scientific title
Randomized, Controlled Phase 2a/b Study of the Efficacy and Safety of PEG-rIL-29 Administered in Combination With Ribavirin to Treatment-Naive Subjects With Chronic Hepatitis C Virus Infection
Secondary ID [1] 0 0
2009-011786-80
Secondary ID [2] 0 0
526H04
Universal Trial Number (UTN)
Trial acronym
EMERGE
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
Studies of infection and infectious agents
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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - PEG-rIL-29
Treatment: Drugs - Peginterferon alfa-2a
Treatment: Drugs - Ribavirin

Experimental: PEG-rIL-29 at 120 µg -

Experimental: PEG-rIL-29 at 180 µg -

Active comparator: Peginterferon alfa-2a at 180 µg -


Treatment: Drugs: PEG-rIL-29
Weekly SC injections in combination with ribavirin for up to 48 weeks

Treatment: Drugs: Peginterferon alfa-2a
Weekly SC injections in combination with ribavirin for up to 48 weeks

Treatment: Drugs: Ribavirin
Daily oral administration (400-600 mg BID)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HCV RNA
Timepoint [1] 0 0
At week 12, week 24, or week 48
Primary outcome [2] 0 0
Incidence and severity of adverse events
Timepoint [2] 0 0
Through week 12, week 40, or week 48
Secondary outcome [1] 0 0
Incidence and severity of adverse events and laboratory abnormalities
Timepoint [1] 0 0
Up to week 72
Secondary outcome [2] 0 0
HCV RNA
Timepoint [2] 0 0
Up to week 72
Secondary outcome [3] 0 0
PD biomarkers
Timepoint [3] 0 0
Up to week 72
Secondary outcome [4] 0 0
Quality of life assessments
Timepoint [4] 0 0
Up to week 72
Secondary outcome [5] 0 0
Serum drug concentration profile
Timepoint [5] 0 0
Up to week 48

Eligibility
Key inclusion criteria
* No prior therapy for chronic HCV, other than up to 2 weeks of single-agent therapy with a direct-acting antiviral agent, including but not limited to, a protease or polymerase inhibitor
* HCV genotype 1, 2, 3, or 4
* HCV RNA =100,000 IU/mL
* ALT and AST =5.0 × ULN
* Documented absence of cirrhosis
* Able to comprehend the investigational nature of this study and sign an informed consent form
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Mixed genotype HCV infection
* Current or prior history of decompensated liver disease
* Received any investigational drug, including a direct-acting antiviral agent, within 60 days prior to receiving study drug
* Positive test for hepatitis B surface antigen, human immunodeficiency virus (HIV)-1, or HIV2 antibody at screening
* Active substance abuse, such as alcohol, or inhaled or injected drugs, within 6 months

Additional inclusion and exclusion criteria are specified in the protocol.

Study design
Purpose of the study
Treatment
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
UNKNOWN
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2012
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
- Herston
Recruitment hospital [2] 0 0
- Adelaide
Recruitment hospital [3] 0 0
- Camperdown
Recruitment hospital [4] 0 0
- Clayton
Recruitment hospital [5] 0 0
- Fitzroy
Recruitment hospital [6] 0 0
- Fremantle
Recruitment hospital [7] 0 0
- Greenslopes
Recruitment hospital [8] 0 0
- Kogarah
Recruitment hospital [9] 0 0
- Melbourne
Recruitment hospital [10] 0 0
- Penrith
Recruitment hospital [11] 0 0
- Perth
Recruitment hospital [12] 0 0
- Westmead
Recruitment postcode(s) [1] 0 0
- Herston
Recruitment postcode(s) [2] 0 0
- Adelaide
Recruitment postcode(s) [3] 0 0
- Camperdown
Recruitment postcode(s) [4] 0 0
- Clayton
Recruitment postcode(s) [5] 0 0
- Fitzroy
Recruitment postcode(s) [6] 0 0
- Fremantle
Recruitment postcode(s) [7] 0 0
- Greenslopes
Recruitment postcode(s) [8] 0 0
- Kogarah
Recruitment postcode(s) [9] 0 0
- Melbourne
Recruitment postcode(s) [10] 0 0
- Penrith
Recruitment postcode(s) [11] 0 0
- Perth
Recruitment postcode(s) [12] 0 0
- Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Minnesota
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
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United States of America
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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United States of America
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Pennsylvania
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United States of America
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Texas
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United States of America
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Utah
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United States of America
State/province [16] 0 0
Virginia
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United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
Austria
State/province [18] 0 0
Graz
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Austria
State/province [19] 0 0
Innsbruck
Country [20] 0 0
Austria
State/province [20] 0 0
Linz
Country [21] 0 0
Austria
State/province [21] 0 0
Wien
Country [22] 0 0
Canada
State/province [22] 0 0
British Columbia
Country [23] 0 0
Canada
State/province [23] 0 0
Ontario
Country [24] 0 0
France
State/province [24] 0 0
Paris
Country [25] 0 0
France
State/province [25] 0 0
Pessac
Country [26] 0 0
Germany
State/province [26] 0 0
Bochum
Country [27] 0 0
Germany
State/province [27] 0 0
Dusseldorf
Country [28] 0 0
Germany
State/province [28] 0 0
Essen
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Germany
State/province [29] 0 0
Frankfurt/Main
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Germany
State/province [30] 0 0
Freiburg
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Germany
State/province [31] 0 0
Goettingen
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Germany
State/province [32] 0 0
Hamburg
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Germany
State/province [33] 0 0
Hannover
Country [34] 0 0
Germany
State/province [34] 0 0
Heidelberg
Country [35] 0 0
Germany
State/province [35] 0 0
Koln
Country [36] 0 0
Germany
State/province [36] 0 0
Mainz
Country [37] 0 0
Germany
State/province [37] 0 0
Munchen
Country [38] 0 0
Germany
State/province [38] 0 0
Tubingen
Country [39] 0 0
Italy
State/province [39] 0 0
Milano
Country [40] 0 0
Poland
State/province [40] 0 0
Bialystok
Country [41] 0 0
Poland
State/province [41] 0 0
Krakow
Country [42] 0 0
Poland
State/province [42] 0 0
Lancut
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Poland
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Raciborz
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Poland
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Wroclaw
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Puerto Rico
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Santurce
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Romania
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Bucharest
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Romania
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Iasi
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Romania
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Timisoara
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Majadahonda
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Spain
State/province [52] 0 0
Sevilla
Country [53] 0 0
Spain
State/province [53] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ZymoGenetics
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Bristol-Myers Squibb
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Interleukin 29 (IL-29) is a substance that is produced in the body to help fight viral infections. The purpose of this study is to evaluate the safety and antiviral effects of several different doses of PEG-rIL-29 (a man-made form of IL-29) when it is given in combination with daily oral doses of ribavirin (an antiviral drug) to subjects with hepatitis C infection who have received no prior treatment for this disease.
Trial website
https://clinicaltrials.gov/study/NCT01001754
Trial related presentations / publications
Wang X, Hruska M, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 1: Modeling optimal treatment duration and sustained virologic response rates. J Clin Pharmacol. 2015 Jan;55(1):63-72. doi: 10.1002/jcph.363. Epub 2014 Jul 24.
Hruska M, Wang X, Chan P, Ahmad A, Freeman J, Horga MA, Hillson J, Kansra V, Lopez-Talavera JC. Derivation of Phase 3 dosing for peginterferon lambda-1a in chronic hepatitis C, Part 2: Exposure-response analyses for efficacy and safety variables. J Clin Pharmacol. 2015 Jan;55(1):73-80. doi: 10.1002/jcph.361. Epub 2014 Jul 24.
Public notes

Contacts
Principal investigator
Name 0 0
Jan Hillson, MD
Address 0 0
ZymoGenetics
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/study/NCT01001754