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A Phase II, Randomized, Multi-center, Two Part Study of the Safety and Efficacy of Double-blind, Placebo-controlled INX-08189 in Adjunctive Treatment With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Study Part A, and Open-label INX-08189 in Adjunctive (Interferon Free) Treatment With Daclatasvir and/or Ribavirin (Copegus®) in Study Part B, in Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects

Phase 2
18 Years
65 Years
Not Enrolling
Hepatitis C

Thank you

Trial Information

A Phase II, Randomized, Multi-center, Two Part Study of the Safety and Efficacy of Double-blind, Placebo-controlled INX-08189 in Adjunctive Treatment With Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®) in Study Part A, and Open-label INX-08189 in Adjunctive (Interferon Free) Treatment With Daclatasvir and/or Ribavirin (Copegus®) in Study Part B, in Chronically-infected HCV Genotype 2 and 3 Treatment-naive Subjects

Data Monitoring Committee is appointed for Part A only

Masking: Part A of this study is Double blind and the Part B is Open Label

Inclusion Criteria:

Amendment 4: Genotype 1, 10 subjects at site 401.

- Males and females, 18 to 65 years of age inclusive with a body mass index (BMI) of at
least 18 kg/m2 but not exceeding 36 kg/m2

- Diagnosed with chronic HCV at least 6 months prior to Visit 1 with medical
documentation (e.g., prior PCR result, prior liver biopsy, prior genotyping, etc.),
with a positive HCV viral load of at least 50,000 IU/mL at Visit 1 (screening) as
measured by quantitative PCR

- Chronic genotype 2 or 3 HCV infection (per polymerase chain reaction [PCR]

- HCV treatment-naïve where "treatment-naïve" is defined as no prior treatment with IFN
alfa 2a or 2b, Pegylated IFN alfa-2a, Ribavirin, or any HCV direct-acting anti-viral

- Liver biopsy consistent with chronic HCV infection but with a classification of
non-cirrhotic (and without classification of 'transition to cirrhosis or borderline
cirrhosis') as judged by a pathologist (defined as Knodell ≤ 3, Metavir ≤ 2, Ishak ≤
4, or Batts &Ludwig ≤ 2 ) within the last two years and before Visit 2 (biopsy can
be done after Visit 1 and before Visit 2, within the screening period)

- Negative urine drug screen for drugs of abuse and methadone (via central lab-provided
dipstick at site) at screening (Visit 1) (note: subjects with a valid prescription
for a drug which can be abused [e.g., benzodiazepine, opiates] can be enrolled on the
judgment of the investigator)

- Females will have a negative serum beta human chorionic gonadotropin (βHCG) pregnancy
test at screening and a negative urine dipstick pregnancy test on Study Day 0 (visit

- Agreement by both female subjects of childbearing potential and male subjects (who
have not been surgically sterilized) to practice an acceptable method of birth
control, which includes at least one barrier during the study and for at least 6
months after the cessation of treatment. Surgical sterilization of either the female
or the male partner must have occurred at least 6 months prior to the first dose and
females must be post-menopausal for 2 years to be considered of non-child-bearing
potential. Acceptable contraceptive methods include one of the following: Oral and
implantable hormonal contraceptives by the female partner for at least 3 months prior
to the first dose of Study Drug with additional use of a barrier method, IUD in place
for at least 6 months prior to first dose with additional use of barrier method.
Acceptable barrier methods include either diaphragm with spermicide, and condom with
spermicide. (Note: Abstinence is not an acceptable method of birth control, subjects
who indicate sexual inactivity must agree to utilize an acceptable method of birth
control in the event of sexual activity)

- Willing and able to complete all study visits and procedures, and able to effectively
communicate with the investigator and other testing center personnel

- Signed informed consent form (ICF) executed prior to protocol screening assessments

Exclusion Criteria:

- Signs or symptoms of decompensated liver disease such as variceal bleeding, ascites,
hepatic encephalopathy, active jaundice defined by an indirect bilirubin > 2, Alanine
transaminase (ALT) or Aspartate aminotransferase (AST) laboratory values ≥ 10 times
the upper limit of normal, or other evidence of decompensated liver disease, or
hepatocellular carcinoma

- Chronic liver disease other than HCV not limited to Hepatitis B virus (HBV) [positive
test for hepatitis B surface antigen (HBsAg)], hemochromatosis, auto-immune
hepatitis, alcoholic liver disease or non-alcoholic fatty liver disease

- History of liver transplantation

- Co-infection with Human immunodeficiency virus (HIV) [positive test for anti-HIV Ab]
or use of didanosine

- History of a heart attack, cardiac ischemia, heart disease, clinically symptomatic
cardiac abnormalities, or blood clots, based on medical history or apparent on
physical exam

- QTcF interval at Visit 1 of greater than or equal to 450 ms by Fridericia's
correction, or a personal or family history of Torsades de Pointe

- History or presence of sarcoidosis or pancreatitis

- History or presence of severe pulmonary function impairment including severe (> GOLD
stage III) chronic obstructive pulmonary obstructive disease, and moderate to severe

- Uncontrolled diabetes mellitus as evidenced by HbA1C ≥ 8.5% at screening (Visit 1)

- Use of the following medications concurrently or within the 30 days prior to
Screening (Visit 1) associated with QT prolongation: macrolides, antiarrhythmic
agents, azoles, fluoroquinolones, and tricyclic anti-depressants (specifically
excluded medication will be listed in protocol Section 6.8)

- Use of immunosuppressive or immune-modulating agents (including azathioprine,
corticosteroids and immunosuppressive agents) or presence of an
immunologically-mediated autoimmune disease (other than asthma) or history of solid
organ or bone marrow transplantation (note: inhaled steroids for mild/moderate asthma
and topical steroid for minor skin conditions allowed and washout period for per
Oral (PO)/Intramuscular (IM)/ Intravenous (IV) corticosteroid use is 8 weeks; washout
periods for other immunosuppressives determined by Medical Monitor)

- Use of strong CYP3A4-inhibiting protease inhibitors (specifically Atazanavir,
Indinavir, Nelfinavir, Saquinavir, and Ritonavir), strong CYP3A4 inhibitors
(specifically Clarithromycin, Itraconazole, Ketoconazole, Nefazodone, Telithromycin),
or strong CYP3A4 inducers (specifically Rifampin, Efavirenz, Etravirine,
Phenobarbital, Phenytoin, and Carbamazepine)

- Absolute neutrophil count of < 1800 cells/mm3, or platelet count < 130,000 cells/mm3,
or hemoglobin < 12 g/dl for women and < 13 g/dl for men, or a history of anemia,
sickle cell anemia, or thalassemia; (note: if baseline value within 5% of minimum
qualifying value, one re-test allowed for the purpose of qualifying for study)

- A history or presence of abnormal thyroid function that is not adequately controlled
[defined as Thyroid-stimulating hormone (TSH) levels less than 0.8 x lower limit of
normal (LLN) or greater than 1.2 x the upper limit of normal (ULN)]

- Creatinine clearance < 50 mL/minute, serum creatinine concentration ≥ 1.5 times the
ULN, or albumin ≤ 3 g/dl

- Presence or history of bipolar disorder, schizophrenia, psychosis, or unstable
psychiatric condition, or hospitalization for psychiatric condition, or suicide
attempt. (Note: Subjects with psychiatric conditions need to be adequately treated
and on stable doses of appropriate medications for at least 3 months prior to Visit
1. History of suicidal ideation within prior 3 months is exclusionary)

- Any malignancy within the last 5 years other than treated cervical carcinoma in situ
or treated basal cell carcinoma with no more than 20% risk of recurrence within 2

- Alcohol abuse by the assessment of the investigator within the past 2 years or an
alcohol use pattern that will interfere with the study conduct

- Drug abuse by the assessment of the investigator within the last six months

- Pregnancy, current lactation in female subjects, or male subjects with partners who
are pregnant, or females intending to become pregnant

- Major surgery within 30 days prior to Visit 1

- Participation in another clinical trial of an investigational drug or device within
6 months prior to Visit 1 unless that prior participation involved exposure only to
placebo by clear and available documentation

- Donation of blood or plasma within 30 days prior to Visit 1 (not including routine
laboratory assessments)

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Part A: Change in Hepatitis C Viral Load Measurements at protocol specific timepoints

Outcome Time Frame:

Weeks -6, 0, 1, 2, 3, 4, 6, 8, 10, 12, 16, 20, 24, 28, 36, 48

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

August 2011

Completion Date:

July 2013

Related Keywords:

  • Hepatitis C
  • Inhibitex
  • Chronic Hepatitis
  • Hepatitis C Virus
  • Hepatitis
  • Hepatitis A
  • Hepatitis C



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