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Hepatitis, Chronic ActivePhase 2NCT00277238

CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Non-Responder (Null And Partial Responder) Hepatitis C Virus (HCV) Genotype 1 Infected Subjects

A Phase 2 study testing CPG10101 in people with Hepatitis, Chronic Active, run by Pfizer at 14 sites in United States.

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 this study is to determine the efficacy and tolerability of CPG 10101 at two different dose levels with pegylated-interferon-alpha 2B (PEG-IFN) plus ribavirin (RBV) compared to PEG-IFN and RBV without CPG 10101 in HCV positive subjects who were classified as non-responders to previous adequate PEG-IFN… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis, Chronic Active
What is being tested?
CPG10101
Could I receive a placebo?
No, everyone receives an active treatment
How many people
113 participants
Where
14 sitesUnited States
Study dates
Feb 2006to Jul 2007
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • HCV positive subjects documented by serum HCV RNA concentration > 100,000 IU/mL within 21 days of first study treatment Receipt of adequate previous PEG-IFN and RBV therapy for a minimum of 12 weeks (PEG-IFN alpha-2a doses of > 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) not resulting in a minimum of a 2 log decrease in HCV RNA concentrations while on treatment (null responders). Or, receipt of adequate previous treatment PEG-IFN and RBV therapy for a minimum of 24 weeks (PEG-IFN alpha-2a doses of ≥ 180 μg/wk or PEG-IFN alpha-2b 1.5 µg/kg/wk and at least 800 mg RBV daily) resulting in a minimum of a 2 log decrease in serum HCV RNA concentrations by 12 weeks of treatment but not resulting in an undetectable viral load after 24 weeks of treatment (partial responders). If dose modifications were necessary during the treatment due to adverse events, the subject must have received at least 80% of the PEG-IFN dose and 80% of the RBV dose to be eligible for the study.
  • HCV genotype 1 only; other HCV genotypes are excluded. Adults, 18+ years old Written informed consent Liver biopsy within 5 years of the first dose of study drug, documenting changes consistent with hepatitis C
  • Adequate bone marrow, liver, and renal function demonstrated by:
  • Hemoglobin > 12 g/dL for females and > 13 g/dL for males
  • White blood cell (WBC) > 3,000/mm3
  • Neutrophils > 1,500/mm3
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  • Platelets > 80,000/mm3
  • Total bilirubin < 1.6 mg/dL
  • Direct bilirubin < 1.5 upper limit of normal. If indirect bilirubin is elevated, Gilbert's disease must be documented in chart and substantiated.
  • Albumin > 3.7 g/dL and < 4.9 g/dL
  • Serum creatinine < upper limit of normal per central laboratory. If serum creatinine is > upper limit of normal then calculated creatinine clearance has to be > 100 mL/min (by Cockcroft-Gault formula) for patient to be eligible.
  • Negative pregnancy test in women of childbearing potential. Females of childbearing potential and males who have partners of childbearing potential must use two forms of effective contraception during treatment and during the 6 months after treatment has been concluded.
  • Serum thyroid stimulating hormone (TSH) levels within normal ranges within 21 days of first study treatment, regardless of treatment with L-thyroxin.

Who cannot join

  • Treatment with any IFN based therapies and/or antiviral therapies within 30 days of the first dose of study drug Subjects who have previously received an HCV vaccine Child-Pugh Class B or C History of psychiatric conditions including, but not limited to, psychosis, suicidal ideations, or major depression. Subjects with mild to moderate depression in the past who have a normal to mild Beck Depression Inventory score and no prior history of suicidal gestures or attempts may be enrolled if, in the Investigator's opinion, they are suitable for treatment.
  • Significant cardiovascular disease (e.g., New York Heart Association [NYHA] class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; or uncontrolled atrial or ventricular cardiac arrhythmias) History of immunodeficiency or autoimmune disease including autoimmune hepatitis, allogeneic transplant, or pre-existing autoimmune or antibody-mediated disease including, but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogren's syndrome, or autoimmune thrombocytopenia.
  • Other serious medical conditions including, but not limited to:
  • HIV-1
  • Hepatitis B (positive hepatitis B surface antigen [HBsAg])
  • Cancer (active tumors in the last 5 years)
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  • Pregnant, partners of pregnant women, or nursing women
  • Alcohol or drug misuse within 90 days of screening Use of immunosuppressive doses of steroids or any anti-metabolite therapies within 3 months of entry into the study (inhaled and topical corticosteroids are permitted).
  • Receipt of any vaccine or immunoglobulin within 30 days before the first dose of study drug. Flu vaccines are only allowed once the subjects are qualified for 36 additional weeks of treatment.
  • Prior administration of oligodeoxynucleotides (including study medication CPG 10101), ribozymes, or any known allergy to CPG 10101, interferon, RVN or their excipients.
  • Receipt of any investigational drug therapy within 30 days before the first dose of study drug.
  • Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the subject or would preclude the subject from successful completion of the study.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • Pfizer Investigational Site

    Chicago, Illinois, 60611

  • Pfizer Investigational Site

    Cleveland, Ohio, 44195

  • Pfizer Investigational Site

    Dallas, Texas, 75208

  • Pfizer Investigational Site

    Detroit, Michigan, 48202-2689

  • Pfizer Investigational Site

    Durham, North Carolina, 27710

  • Pfizer Investigational Site

    Germantown, Tennessee, 38138

  • Pfizer Investigational Site

    Hershey, Pennsylvania, 17033

  • Pfizer Investigational Site

    Indianapolis, Indiana, 46202

  • Pfizer Investigational Site

    Kansas City, Missouri, 64131

  • Pfizer Investigational Site

    New Orleans, Louisiana, 70115

  • Pfizer Investigational Site

    New York, New York, 10021

  • Pfizer Investigational Site

    Richmond, Virginia, 23249

  • Pfizer Investigational Site

    San Antonio, Texas, 78215

  • Pfizer Investigational Site

    St Louis, Missouri, 63104

Other trials in United States

About this study

Official title: CPG 10101 Combination Therapy for the Treatment of Hepatitis C: A Phase II Randomized, Open Label, Multi-Center, Parallel Arm, Controlled Trial of CPG 10101 at Two Different Dose Levels With Pegylated-Interferon-Alpha 2B (PEG-IFN) Plus Ribavirin (RBV) or PEG-IFN Plus RBV Without CPG 10101 in the Treatment of Non-Responder (Null and Partial Responder) HCV Genotype 1 Infected Subjects

The purpose of this study is to determine the efficacy and tolerability of CPG 10101 at two different dose levels with pegylated-interferon-alpha 2B (PEG-IFN) plus ribavirin (RBV) compared to PEG-IFN and RBV without CPG 10101 in HCV positive subjects who were classified as non-responders to previous adequate PEG-IFN plus RBV therapy.

Being tested
CPG10101, Control
Keywords
HCV, Hepatitis c virus, Virus diseases, Interferon-alpha, Interferons, Liver diseases
Medical subject headings
Hepatitis, Chronic, Hepatitis C, Virus Diseases, Liver Diseases

What participants receive

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

  • CPG10101Drug

    CPG10101, subcutaneous, 0.2mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks

  • CPG10101Drug

    CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks

  • ControlDrug

    Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 12wks

  • CPG10101Drug

    CPG10101, subcutaneous, 0.5mg/kg, weekly, 24wks Pegylated interferon alfa-2b, subcutaneous, 1.5 ug/kg, weekly, 24wks Ribavirin, oral, 800-1400mg/day (weight-based), daily, 24wks

Study groups in NCT00277238
Study groupRoleWhat they receive
CPG10101 (0.2) + pegylated inteferon + ribavirinExperimentalNot described
Receives: Drug: CPG10101
CPG10101 (0.5) + pegylated inteferon + ribavirinExperimentalNot described
Receives: Drug: CPG10101
Pegylated interferon + ribavirinActive comparatorNot described
Receives: Drug: Control
CPG10101 + pegylated interferon + ribavirin (rollover)ExperimentalNot described
Receives: Drug: CPG10101

What is being measured

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

  1. Serum HCV RNA concentrations, over 12wks, relative to baseline, early virologic response (EVR)

    Measured: 12wks

  2. Serum HCV RNA concentrations, 6months after treatment completed, relative to baseline, sustained virologic response (SVR)

    Measured: 72wks

Secondary outcomes (5)

  1. Safety and Tolerability: adverse events, vital signs, clinical and laboratory parameters, depression score, physical exam, electrocardiogram (ECG), ophthalmologic exam (if required)

    Measured: 28wks

  2. Dose exposure

    Measured: 24wks

  3. Child-Pugh score

    Measured: 24wks

  4. Serum Biomarkers: cytokines and chemokines, over time, relative to baseline

    Measured: 24wks

  5. Immunophenotyping profile, over time, relative to baseline, HCV specific immune response, over time, relative to baseline, level of innate immune activation at baseline

    Measured: 24wks

Timeline

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

  1. First posted16 Jan 2006 (estimated)
  2. Study startFeb 2006
  3. Primary completionJul 2007
  4. Study completionJul 2007

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
None (open label)
Enrolment
113 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00277238
Sponsor's protocol ID
B1211002
Other IDs
CPG 10101-004
Status last verified
Mar 2017
First submitted
13 Jan 2006
Last updated
8 Mar 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CPG10101 in people with Hepatitis, Chronic Active, run by Pfizer at 14 sites in United States.

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 13 inclusion and 12 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 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. 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?

Serum HCV RNA concentrations, over 12wks, relative to baseline, early virologic response (EVR) (time frame: 12wks). 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 NCT00277238.

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 8 Mar 2017.

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