Hepatitis C Virus (HCV)Phase 3NCT01447394

Safety and Efficacy Study of Pegylated Interferon Lambda Versus Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C

A Phase 3 study testing Pegylated Interferon Lambda, Pegylated Interferon Alfa-2a and Ribavirin in people with Hepatitis C Virus (HCV), run by Bristol-Myers Squibb at 100 sites in 20 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

The purpose of this study is to determine if 48 weeks of therapy with Pegylated Interferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Pegylated Interferon Alfa-2a plus Ribavirin. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Hepatitis C Virus (HCV)
What is being tested?: Pegylated Interferon Lambda, Pegylated Interferon 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: 0 participants
Where: 100 sitesin 20 countries
Study dates: Mar 2012to Aug 2014
Phase: Phase 3
Are there results?: None posted in the registry

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

Chronic hepatitis C, Genotype 1 or 4
HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
Naive to prior anti-HCV therapy

Who cannot join

Infected with HCV other than Genotype 1 or 4
Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
Evidence of liver disease other than HCV
Active substance abuse
Use of hematologic growth factors within 90 days prior to study randomization
Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria

Trial locations and contacts

100 sites in 20 countries.

Country

City, postcode or hospital

100 sites in 20 countries

Russia19 sites

Local Institution
Kaluga, 248023
Local Institution
Lipetsk, 398043
Local Institution
Moscow, 111123
Local Institution
Moscow, 115446
Local Institution
Moscow, 117333
Local Institution
Nizhny Novgorod, 603022
Local Institution
Poselok Noviy, 143420
Local Institution
Saint Petersburg, 191167
Local Institution
Saint Petersburg, 193137
Local Institution
Saint Petersburg, 194044
Local Institution
Saint Petersburg, 196645
Local Institution
Saint Petersburg, 198103
Local Institution
Samara, 443077
Local Institution
Saratov, 410009
Local Institution
Smolensk, 214006
Local Institution
Smolensk, 214018
Local Institution
Tolyatti, 445846
Local Institution
Volgograd, 400040
Local Institution
Yoshkar-Ola, Mariy-El Republic, 424006

Other trials in Russia

Poland15 sites

Local Institution
Bialystok, 15-540
Local Institution
Bydgoszcz, 85-030
Local Institution
Chorzów, 41-500
Local Institution
Czeladź, 41-250
Local Institution
Kielce, 25-317
Local Institution
Krakow, 31-501
Local Institution
Lodz, 91-347
Local Institution
Lublin, 20-081
Local Institution
Olsztyn, 10-082
Local Institution
Puławy, 24-100
Local Institution
Racibórz, 47-400
Local Institution
Sosnowiec, 41-200
Local Institution
Warsaw, 01-201
Local Institution
Wroclaw, 50-220
Local Institution
Zielona Góra, 65-046

Other trials in Poland

South Korea10 sites

Local Institution
Busan, 609-735
Local Institution
Busan, 614-735
Local Institution
Daegu, 700-721
Local Institution
Incheon, 400-711
Local Institution
Incheon, 403-720
Local Institution
Seoul, 110-744
Local Institution
Seoul, 120-752
Local Institution
Seoul, 135-710
Local Institution
Seoul, 138-736
Local Institution
Suwon, 443-721

Other trials in South Korea

India6 sites

Local Institution
Coimbatore, 641005
Local Institution
Gūrgaon, 122001
Local Institution
Hyderabad, Andhra Pradesh, 500082
Local Institution
Ludhiana, 141001
Local Institution
Nagpur, 440010
Local Institution
New Delhi, 110 070

Other trials in India

Taiwan6 sites

Local Institution
Kaohsiung City, 80756
Local Institution
Kaohsiung City, 833
Local Institution
Taichung, 404
Local Institution
Tainan, 704
Local Institution
Taipei, Taiwan, 100
Local Institution
Taipei, 112

Other trials in Taiwan

Spain5 sites

Local Institution
A Coruña, 15006
Local Institution
Barcelona, 08003
Local Institution
Barcelona, 08035
Local Institution
Barcelona, 08036
Local Institution
Madrid, 28046

Other trials in Spain

Turkey (Türkiye)5 sites

Local Institution
Ankara, 06100
Local Institution
Bornova Izmir, 35100
Local Institution
Diyarbakır, 21280
Local Institution
Istanbul, 34093
Local Institution
Trabzon, 61080

Other trials in Turkey (Türkiye)

Hungary4 sites

Local Institution
Budapest, 1097
Local Institution
Budapest, 1126
Local Institution
Debrecen, 4043
Local Institution
Miskolc, 3529

Other trials in Hungary

Singapore4 sites

Local Institution
Singapore, 119228
Local Institution
Singapore, 169608
Local Institution
Singapore, 308433
Local Institution
Singapore, 529889

Other trials in Singapore

United States3 sites

Local Institution
Houston, Texas, 77230
Local Institution
Rochester, New York, 14642
Local Institution
San Diego, California, 92114

Other trials in United States

Colombia3 sites

Local Institution
Bogotá
Local Institution
Cali
Local Institution
Medellín

Other trials in Colombia

Czechia3 sites

Local Institution
Hradec Králové, 500 05
Local Institution
Prague, 140 21
Local Institution
Ústí nad Labem, 400 01

Other trials in Czechia

Romania3 sites

Local Institution
Bucharest, 021105
Local Institution
Iași, 700506
Local Institution
Timișoara, 300002

Other trials in Romania

United Kingdom3 sites

Local Institution
Birmingham, West Midlands, B15 2TH
Local Institution
Edinburgh, Midlothian, EH4 2XU
Local Institution
London, Greater London, W2 1NY

Other trials in United Kingdom

Canada2 sites

Local Institution
Vancouver, British Columbia, V5Z 1H2
Local Institution
Vaughan, Ontario, L4L 4Y7

Other trials in Canada

Egypt2 sites

Local Institution
Cairo, 11559
Local Institution
Shebin Elkom, Monufia Governorate, 35111

Other trials in Egypt

Hong Kong2 sites

Local Institution
Lai Chi Kok
Local Institution
Tai Po

Other trials in Hong Kong

Ireland2 sites

Local Institution
Dublin, Dublin, DUBLIN 7
Local Institution
Dublin, Dublin

Other trials in Ireland

Netherlands2 sites

Local Institution
Amsterdam, 1105 AZ
Local Institution
Leiden, 2300

Other trials in Netherlands

China1 site

Local Institution
Hong Kong, Hong Kong, 0

Other trials in China

About this study

Official title: A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects

Conditions: Hepatitis C Virus (HCV)
Being tested: Pegylated Interferon Lambda, Pegylated Interferon Alfa-2a, Ribavirin
Medical subject headings: Hepatitis C

What participants receive

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

Pegylated Interferon LambdaBiological
Also called BMS-914143
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
Pegylated Interferon Alfa-2aBiological
Also called Pegasys
Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
RibavirinDrug
Also called Ribasphere
Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

Study groups in NCT01447394
Study group	Role	What they receive
Arm 1: Pegylated Interferon Lambda + Ribavirin	Experimental	Not described Receives: Biological: Pegylated Interferon Lambda; Drug: Ribavirin
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin	Active comparator	Not described Receives: Biological: Pegylated Interferon Alfa-2a; Drug: Ribavirin

What is being measured

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

Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
Measured: At follow-up Week 24 (SVR24) following 48 weeks of treatment
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities
Measured: From Day 1 to end of Week 48 on-treatment

Secondary outcomes (1)

Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms
Measured: From Day 1 to end of Week 48 on-treatment

Timeline

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

Mar 2012Aug 2014

First posted6 Oct 2011 (estimated)
Study startMar 2012
Primary completionMar 2014 (estimated)
Study completionAug 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hepatitis C Virus (HCV)Studies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01447394
Sponsor's protocol ID: AI452-013
Other IDs: 2011-003748-31
Status last verified: Feb 2012
First submitted: 4 Oct 2011
Last updated: 3 Feb 2012
Results posted: No
Data monitoring committee: No

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
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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

All Hepatitis C Virus (HCV) trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-Blinded Randomized Control Study Evaluating the Efficacy and Safety of Pegylated Lambda Interferon Compared to Pegylated Alfa-2a Interferon, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 or 4 Chronic Hepatitis C Subjects
ClinicalTrials.gov ID: NCT01447394
Acronym / sponsor ID: AI452-013
Conditions: Hepatitis C Virus (HCV)
Phase: Phase 3
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: Mar 2012
Primary completion: Mar 2014 (estimated)
Study completion: Aug 2014 (estimated)
First posted: 6 Oct 2011 (estimated)
Results: Not posted in the source record

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: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Arm 1: Pegylated Interferon Lambda + Ribavirin	Experimental	Biological: Pegylated Interferon Lambda, Drug: Ribavirin
Arm 2: Pegylated Interferon Alfa-2a + Ribavirin	Active comparator	Biological: Pegylated Interferon Alfa-2a, Drug: Ribavirin

Who may qualify

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

Key inclusion criteria (4 listed)

Chronic hepatitis C, Genotype 1 or 4
HCV Ribonucleic acid (RNA) ≥ 100,000 IU/mL at screening
Liver biopsy documenting no cirrhosis (within prior 2 years) or cirrhosis (from any time prior to randomization). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease. Subjects with compensated cirrhosis can enroll and will be capped at 10%
Naive to prior anti-HCV therapy

Key exclusion criteria (6 listed)

Infected with HCV other than Genotype 1 or 4
Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody or hepatitis D virus (HDV) at screening
Evidence of liver disease other than HCV
Active substance abuse
Use of hematologic growth factors within 90 days prior to study randomization

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
Pegylated Interferon LambdaAlso: BMS-914143Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks	Biological	Arm 1: Pegylated Interferon Lambda + Ribavirin
Pegylated Interferon Alfa-2aAlso: PegasysSyringe, Subcutaneous, 180 μg, Once weekly, 48 weeks	Biological	Arm 2: Pegylated Interferon Alfa-2a + Ribavirin
RibavirinAlso: RibasphereTablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks	Drug	Arm 1: Pegylated Interferon Lambda + Ribavirin, Arm 2: Pegylated Interferon Alfa-2a + Ribavirin

Primary outcome

Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response
Time frame: At follow-up Week 24 (SVR24) following 48 weeks of treatment
The safety of Lambda + RBV compared to Alfa + RBV in reducing cytopenic abnormalities
Time frame: From Day 1 to end of Week 48 on-treatment

1 secondary outcome

Proportion of interferon-associated symptoms: a) Flu-like symptoms b) Musculoskeletal symptoms c) Neurologic symptoms d) Psychiatric symptoms e) Constitutional symptoms
Time frame: From Day 1 to end of Week 48 on-treatment

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2012.

Related trials for Hepatitis C Virus (HCV)

RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Not yet recruitingObservational study
Elimination of Hepatitis C Virus Among Users of Substances
Hepatitis C in Substance Users
Not yet recruiting
Clinical Study to Evaluate the Performance of the INSTI® HCV Antibody Test for CLIA-Waived Use
HCV Infection
Not yet recruiting
Study to Evaluate the Performance of the INSTI® HCV Antibody Test for Point-of-Care Use in Individuals at Risk for HCV Infection or Presenting With Signs or Symptoms of HCV Infection
HCV Infection
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

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.

Bristol-Myers Squibb study director

Bristol-Myers Squibb

100 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pegylated Interferon Lambda, Pegylated Interferon Alfa-2a and Ribavirin in people with Hepatitis C Virus (HCV), run by Bristol-Myers Squibb at 100 sites in 20 countries.

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 4 inclusion and 6 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: withdrawn, as of the sponsor's last update on 3 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 100 sites in Russia, Poland, South Korea, India, Taiwan and 15 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

Efficacy of Lambda + Ribavirin (RBV) compared to Alfa + RBV in achieving a sustained virological response (time frame: At follow-up Week 24 (SVR24) following 48 weeks of treatment). 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 NCT01447394.

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 3 Feb 2012.