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Hepatitis C, ChronicPhase 2SELECT-2NCT00863239

Phase 2B Dose Ranging Study of Locteron Plus Ribavirin to Treat HCV

A Phase 2 study testing ribavirin and PEG-Intron™ in people with Hepatitis C, Chronic, run by Biolex Therapeutics, Inc. at 24 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly. Read more about this study

Who is it for?
Ages 18 to 69 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
ribavirin and PEG-Intron™
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
24 sitesin 4 countries
Study dates
Mar 2009to Nov 2011
Phase
Phase 2
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 69 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male and female subjects 18 through 69 years of age, inclusive
  • Chronic hepatitis C genotype 1
  • HCV ribonucleic acid (RNA) level > 10,000 IU/mL (by RT-PCR) at screening
  • Creatine clearance ≥ 50 mL/min
  • Neutrophil count > 1500 cells/mm3
  • Platelet count > 90,000/mm3
Show all 10Show fewer
  • Hemoglobin > 12 g/dL for females and > 13 g/dL for males
  • Female subjects of child-bearing potential agreeing to use dual methods for contraception
  • Male subjects with female sexual partners agreeing to use effective birth control methods
  • Negative serum pregnancy test for women of child-bearing potential • Compensated liver disease defined as INR < 1.5, conjugated bilirubin < 1.5 X ULN, serum albumin > 3.0 g/dL.

Who cannot join

  • Prior antiviral treatment for hepatitis C
  • Co-infection with HIV or hepatitis B virus
  • Subjects with a body mass index (BMI) above 32 kg/m2
  • Current or prior history of clinical hepatic decompensation
  • Evidence of HCC
  • Uncontrolled diabetes mellitus as evidenced by HbA1C ≥ 8.5% at screening
Show all 23Show fewer
  • Known hypersensitivity to interferon alfa or ribavirin
  • Chronic liver disease other than HCV not limited to HBV, hemochromatosis, auto-immune hepatitis, alcoholic liver disease, non-alcoholic fatty liver disease)
  • Clinically significant hemoglobinopathy such as thalassemia major and sickle cell anemia
  • History of moderate, severe or uncontrolled psychiatric disease including depression and prior suicide attempts
  • History of immune-mediated disease
  • Significant renal or neurological disease
  • Severe degree (> GOLD stage III) of chronic pulmonary disease (COPD) or active, severe asthma
  • Subjects with severe cardiac disease (e.g., heart failure, recent [i.e., within 6 months prior to first dosing] myocardial infarction, angina, serious arrhythmias, including prolonged QTc [> 450 mSec], uncontrolled hypertension)
  • History of significant central nervous system (including CNS trauma) or seizure disorders
  • Cancer within the last 5 years, or previous cancer with a high risk of recurrence, including metastatic breast cancer; non-melanoma skin cancer is not an exclusion criterion
  • History of solid organ or bone marrow transplantation
  • Clinical or laboratory evidence of uncontrolled thyroid disease, e.g., by thyroid stimulating hormone (TSH) level > 1.2 X upper limit of normal
  • Clinically significant retinopathy; this needs to have been excluded by an eye exam performed by an ophthalmologist within the last 6 months prior to screening for subjects with hypertension or diabetes mellitus
  • Drug abuse or alcohol consumption within the last 6 months which, in the opinion of the investigator, may affect study participation or outcome. Subjects in a supervised methadone treatment program on a stable regimen for > 6 months may be considered
  • Taken any experimental agent within 12 weeks prior to screening
  • More than 30 days of systemic immunosuppressive medication to include steroids in doses equivalent to or greater than 10 mg prednisone per day within 30 days prior to screening (inhaled corticosteroids are allowed)
  • Nursing mother or male partner of pregnant female.

Trial locations and contacts

24 sites in 4 countries.

24 sites in 4 countries

United States13 sites

  • eStudy site

    Chula Vista, California, 91911

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • The Liver Institute at Methodist Dallas

    Dallas, Texas, 75203

  • AGA Clinical Research Associates, LLC.

    Egg Harbor, New Jersey, 08234

  • Inova Fairfax Hospital

    Falls Church, Virginia, 22042

  • Maryland Digestive Disease Research, LLC

    Laurel, Maryland, 20707

  • University of Louisville Health Care Outpatient Center

    Louisville, Kentucky, 40202

  • eStudy Site

    Oceanside, California, 92056

  • McGuire DVAMC

    Richmond, Virginia, 23249

  • Alamo Medical Center

    San Antonio, Texas, 78215

  • Medical Associates Research Group

    San Diego, California, 92123

  • St. Louis University

    St Louis, Missouri, 63104

  • Montefiore Medical Center

    The Bronx, New York, 10467

Other trials in United States

Bulgaria7 sites

  • Tokuda Hospital

    Sofia, 1407

  • UMHAT "Alexandrovska"

    Sofia, 1431

  • UMHAT "St Ivan Rilski"

    Sofia, 1431

  • UMHAT "Queen Giovanna - ISUL" EAD

    Sofia, 1527

  • Medical Institute Ministry of Interior

    Sofia, 1606

  • Military Medical Academy

    Sofia, 1606

  • UMHAT "St Marina"

    Varna, 9010

Other trials in Bulgaria

Romania3 sites

  • Institute of Infectious Diseases

    Bucharest, 021105

  • Fundeni Clinical Institute

    Bucharest, 022328

  • "Victor Babes" Clinical Hospital Craiova

    Craiova, 200515

Other trials in Romania

Puerto Rico1 site

  • Fundacion de Investigacion de Diego

    Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: Phase 2B, Partially Blinded, Randomized Study in Treatment Naive HCV G1 to Compare the Efficacy, Safety, and Tolerability of Three Doses of Locteron Plus Ribavirin Given Bi-weekly in Comparison With PEG-Intron Plus Ribavirin Given Weekly

The purpose of the study was to assess in subjects with chronic hepatitis C (treatment-naïve, genotype 1) receiving weight-based doses of ribavirin the virologic response to 3 dose levels of Locteron™, dosed every 2 weeks, in comparison with PEG-Intron™ dosed weekly.

Read the detailed description

The aim of SELECT-2 study was to compare the safety and efficacy of Locteron to PegIntron. SELECT-2 was a 72-week Phase 2b, multicenter, international trial of treatment-naïve genotype-1 chronic HCV subjects who were randomized 1:1:1:1 and dosed with one of three doses [640ug (n=29), 480ug (n=29), 320ug (n=28)] of q2week Locteron or weekly doses of 1.5ug/kg PEG2b (n=30). Subjects received these regimens in combination with weight-based ribavirin (800-1400 mg) for up to 48 weeks. Subjects and staff were blinded to Locteron dose for the first 12 weeks. Subjects without early virologic response by 12 weeks, and without viral negativity by 24 weeks, discontinued treatment for lack of efficacy. Adverse events including flu symptoms and depression, Beck Depression Inventory (BDI), Short Form-36, HCV RNA and safety labs were measured at standard intervals at clinic visits through Week 72. In addition, daily subject self-reports of flu symptoms using an electronic subject reporting tool (ePRO) were collected for the first 12 weeks.

Being tested
ribavirin, Locteron™ (controlled-release interferon alpha 2b), PEG-Intron™
Keywords
treatment naive, genotype 1
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • ribavirinDrug

    Also called Ribasphere®

    Co-administered in all arms: oral ribavirin, 200 mg capsules. Subjects with body weight < 65 kg: 800 mg/day; Subjects with body weight 65-85 kg: 1000 mg/day; Subjects with body weight > 85 kg: 1200 mg/day.

  • Locteron™ (controlled-release interferon alpha 2b)Drug

    Also called Locteron, PolyActive, BLX-883

    investigational controlled-release recombinant interferon alpha 2b formulated in 1500/77/23 PolyActive microspheres as a lyophilized powder, reconstituted with carboxymethyl cellulose immediately before subcutaneous injection every other week as part of the treatment of chronic hepatitis C

  • PEG-Intron™Drug

    Also called 12 kDalton pegylated interferon

    commercially available pegylated interferon alpha 2b injected subcutaneously weekly in a dose of 1.5 ug/kg as part of the treatment of chronic hepatitis C

Study groups in NCT00863239
Study groupRoleWhat they receive
1ExperimentalLocteron™ (controlled-release interferon alpha 2b) 320 µg as biweekly subcutaneous injection
Receives: Drug: ribavirin; Drug: Locteron™ (controlled-release interferon alpha 2b)
2ExperimentalLocteron™ (controlled-release interferon alpha 2b) 480 µg as biweekly subcutaneous injection
Receives: Drug: ribavirin; Drug: Locteron™ (controlled-release interferon alpha 2b)
3ExperimentalLocteron™ (controlled-release interferon alpha 2b) 640 µg as biweekly subcutaneous injection
Receives: Drug: ribavirin; Drug: Locteron™ (controlled-release interferon alpha 2b)
4Active comparatorPEG-Intron™ (12 kDalton pegylated interferon alpha 2b) 1.5 µg/kg body weight weekly subcutaneous injection
Receives: Drug: ribavirin; Drug: PEG-Intron™

What is being measured

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

  1. EVR: the proportion of subjects in each arm that have at least a 2 log drop in HCV RNA from Baseline

    Measured: 12 weeks

Secondary outcomes (1)

  1. SVR: the proportion of subjects in each arm demonstrating HCV RNA undetectable (< 10 IU/mL) at the end of the follow-up period

    Measured: 24 weeks

Timeline

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

  1. First posted17 Mar 2009 (estimated)
  2. Study startMar 2009
  3. Primary completionNov 2010
  4. Study completionNov 2011

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00863239
Sponsor's protocol ID
BLX883-203
Acronym
SELECT-2
Status last verified
Feb 2012
First submitted
16 Mar 2009
Last updated
2 Feb 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • 1. Lawitz E, Younossi Z, Mehra P, Rigney A, Krastev Z, Tchernev K, Takov D, Long WA. Early viral response of controlled-release interferon alpha2b and ribavirin vs. pegylated interferon alpha 2b and ribavirin in treatment-naïve genotype1 hepatitis C: 12 week results (SELECT-2 Trial). J Hepatology 52:S114 (abstract 272), 2010. (Presented to 45th Annual Meeting of the European Association for the Study of the Liver, April 15, 2010, Vienna, Austria.) 2. Long WA, Younossi Z, Lawitz E, Kotsev I, Takov D, Tchernev K, Rigney A, Ghalib R, Stoinov S, Balabanska R, Mehra P, Krastev Z. Timing and frequency of depression during HCV-treatment with controlled-release INFa2b (CR2b) vs. pegylated IFNa2b (PEG2b): Results from SELECT-2, a randomized open-label 72-week comparison in 116 treatment-naïve subjects with genotype-1 HCV. J Hepatology 54:S181-182, 2011 (abstract 446). (Presented to the 46th Annual Meeting of the European Association For The Study Of The Liver, Berlin, Germany, March 31, 2011.) 3. Lawitz E, Younossi Z, Mehra P, Rigney A, Krastev Z, Tchernev K, Takov D, Long WA. SVR for controlled-release interferon alpha-2b (CR2b) + ribavirin compared to pegylated intereferon alpha-2b + ribavirin in treatment-naïve genotype-1 (G1) hepatitis C: final results from SELECT-2. J Hepatology 54:S180-181, 2011 (abstract 444). (Presented to the 46th Annual Meeting of the European Association For The Study Of The Liver, Berlin, Germany, March 31, 2011.) 4. Younossi ZM, Lawitz EJ, Krastev Z, Rigney A, Tchernev K, Takov D, Ghalib RH, Long WA. SELECT-2 clinical trial assessing the efficacy and safety of controlled-release interferon alpha-2b (CR2b) +ribavirin (RBV) versus pegylated interferon alpha-2b (PEG2b) +RBV in treatment-naïve genotype-1 (G1) hepatitis C. Gastroenterology 140:S-942, 2011 (abstract su1868). (Presented to Digestive Disease Week 2011, Chicago, Illinois, May 8, 2011.)

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ribavirin and PEG-Intron™ in people with Hepatitis C, Chronic, run by Biolex Therapeutics, Inc. at 24 sites in 4 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 10 inclusion and 23 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: finished, as of the sponsor's last update on 2 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 24 sites in United States, Bulgaria, Romania, Puerto Rico. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

EVR: the proportion of subjects in each arm that have at least a 2 log drop in HCV RNA from Baseline (time frame: 12 weeks). 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 NCT00863239, which also lists 1 linked publication.

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 2 Feb 2012.

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