Hepatitis, Chronic ActivePhase 1NCT00142103
CPG10101 Combination Therapy For The Treatment Of Hepatitis C In Relapsed Hepatitis C Virus (HCV) Subjects
A Phase 1 study testing CPG10101 in people with Hepatitis, Chronic Active, run by Pfizer at 13 sites in United States.
Trial summary
1. To characterize the tolerability profile of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin when administered weekly for twelve weeks in relapsed HCV positive subjects. 2. 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 13 sitesUnited States
- Study dates
- Sep 2005to Feb 2007
- Phase
- Phase 1
- 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 greater than 1000 IU/mL within 21 days of first study treatment.
- Receipt of adequate pegylated IFN plus RVN based therapy for a minimum of 24 weeks (pegylated interferon doses of > 180 μg weekly or > 1.0 μg/kg pegylated interferon weekly and at least 800 mg RVN daily) resulting in undetectable HCV RNA concentrations while on treatment with subsequent relapse (HCV RNA concentration detected) within six months of stopping therapy.
- HCV genotype 1. Adults, 18 + years old. Written Informed Consent. Liver biopsy documenting changes of Hepatitis C within 5 years of the first dose of study drug.
- Adequate bone marrow, liver, and renal function demonstrated by:
- hemoglobin > 12 g/dL for females and > 13 g/dL for males
- WBC > 3,000/mm3
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- Neutrophils > 1,500/mm3
- 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 within normal limits (per central laboratory)
- Serum creatinine < upper limit normal per central laboratory or calculated creatinine clearance > 100 mL/min (by Cockroft-Gault formula).
- Negative pregnancy test in women of child bearing 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.
Who cannot join
- Treatment with IFN based therapies and/or antiviral therapies within 90 days of the first dose of study drug.
- 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., NYHA class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
- History of immunodeficiency, autoimmune disease, 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, autoimmune thrombocytopenia.
- Other serious medical conditions including, but not limited to:
- HIV-1,
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- Hepatitis B (positive HBsAg),
- Cancer,
- Pregnant, partners of pregnant women, or nursing women, and/or
- Alcohol or drug misuse within 90 days of screening Use of immunosuppressive doses of steroids or any antimetabolite 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 Prior administration of oligodeoxynucleotides (including study medication CPG 10101), ribozymes, or any known allergy to CPG 10101, interferon, ribavirin 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
13 sites in 1 country.
13 sites in 1 country
United States13 sites
Pfizer Investigational Site
Charleston, South Carolina, 29425
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
Hershey, Pennsylvania, 17033
Pfizer Investigational Site
Indianapolis, Indiana, 46202
Pfizer Investigational Site
Jackson, Tennessee, 38305-2071
Pfizer Investigational Site
Kansas City, Missouri, 64131
Pfizer Investigational Site
Miami, Florida, 33136
Pfizer Investigational Site
New York, New York, 10021
Pfizer Investigational Site
Richmond, Virginia, 23249
Pfizer Investigational Site
San Antonio, Texas, 78215
About this study
Official title: CPG10101 Combination Therapy For The Treatment Of Hepatitis C: A Phase 1b Open Label Randomized Trial Of CPG10101 Alone, With Interferon, Ribavirin, Or Interferon And Ribavirin In The Treatment Of Relapsed Hepatitis C Virus (HCV) Subjects
- To characterize the tolerability profile of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin when administered weekly for twelve weeks in relapsed HCV positive subjects.
- To assess the effect of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin on serum Hepatitis C Virus (HCV) RNA concentrations
- Conditions
- Hepatitis, Chronic Active
- Being tested
- CPG10101, Control
- Keywords
- Hepatitis c virus, HCV, Liver
- Medical subject headings
- Hepatitis, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPG10101Drug
CPG10101 subcutaneous, 0.20mg/kg, weekly, 12wks
CPG10101Drug
CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks
CPG10101Drug
CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Ribavirin, oral, 800-1400mg, daily, 12wks
CPG10101Drug
CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
ControlDrug
Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
CPG10101Drug
CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks
| Study group | Role | What they receive |
|---|---|---|
| CPG10101 | Experimental | Not described Receives: Drug: CPG10101 |
| CPG10101 + pegylated interferon | Experimental | Not described Receives: Drug: CPG10101 |
| CPG10101 + ribavirin | Experimental | Not described Receives: Drug: CPG10101 |
| CPG10101 + pegylated interferon + ribavirin | Experimental | Not described Receives: Drug: CPG10101 |
| Pegylated inteferon + ribavirin | Active comparator | Not described Receives: Drug: Control |
| CPG10101 + pegylated interferon + ribavirin (rollover) | Experimental | Not described Receives: Drug: CPG10101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events, vital signs, clinical and laboratory parameters, physical exam, ECG
Measured: 16wks
Secondary outcomes (1)
Serum HCV RNA concentrations: Serum HCV concentrations over time to baseline
Measured: 12wks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionFeb 2007
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis, Chronic ActiveStudies of the same condition, open and under way.
- More trials run by PfizerThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00142103
- Sponsor's protocol ID
- B1211001
- Other IDs
- CPG10101-003
- Status last verified
- May 2011
- First submitted
- 31 Aug 2005
- Last updated
- 16 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CPG10101 Combination Therapy For The Treatment Of Hepatitis C: A Phase 1b Open Label Randomized Trial Of CPG10101 Alone, With Interferon, Ribavirin, Or Interferon And Ribavirin In The Treatment Of Relapsed Hepatitis C Virus (HCV) Subjects
- ClinicalTrials.gov ID
- NCT00142103
- Acronym / sponsor ID
- B1211001
- Conditions
- Hepatitis, Chronic Active
- Keywords
- Hepatitis c virus, HCV, Liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Feb 2007 (actual)
- Study completion
- Feb 2007 (actual)
- First posted
- 2 Sep 2005 (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.
- To characterize the tolerability profile of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin when administered weekly for twelve weeks in relapsed HCV positive subjects.
- To assess the effect of subcutaneous (SC) CPG 10101 alone, with pegylated interferon, ribavirin or both pegylated interferon and ribavirin on serum Hepatitis C Virus (HCV) RNA concentrations
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| CPG10101 | Experimental | Drug: CPG10101 |
| CPG10101 + pegylated interferon | Experimental | Drug: CPG10101 |
| CPG10101 + ribavirin | Experimental | Drug: CPG10101 |
| CPG10101 + pegylated interferon + ribavirin | Experimental | Drug: CPG10101 |
| Pegylated inteferon + ribavirin | Active comparator | Drug: Control |
| CPG10101 + pegylated interferon + ribavirin (rollover) | Experimental | Drug: CPG10101 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- HCV positive subjects documented by serum HCV RNA concentration greater than 1000 IU/mL within 21 days of first study treatment.
- Receipt of adequate pegylated IFN plus RVN based therapy for a minimum of 24 weeks (pegylated interferon doses of > 180 μg weekly or > 1.0 μg/kg pegylated interferon weekly and at least 800 mg RVN daily) resulting in undetectable HCV RNA concentrations while on treatment with subsequent relapse (HCV RNA concentration detected) within six months of stopping therapy.
- HCV genotype 1. Adults, 18 + years old. Written Informed Consent. Liver biopsy documenting changes of Hepatitis C within 5 years of the first dose of study drug.
- hemoglobin > 12 g/dL for females and > 13 g/dL for males
- WBC > 3,000/mm3
Key exclusion criteria (11 listed)
- Treatment with IFN based therapies and/or antiviral therapies within 90 days of the first dose of study drug.
- 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., NYHA class 3 congestive heart failure; myocardial infarction within the past 6 months; unstable angina; coronary angioplasty within the past 6 months; uncontrolled atrial or ventricular cardiac arrhythmias).
- History of immunodeficiency, autoimmune disease, 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, autoimmune thrombocytopenia.
- HIV-1,
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 |
|---|---|---|
| CPG10101CPG10101 subcutaneous, 0.20mg/kg, weekly, 12wks | Drug | CPG10101 |
| CPG10101CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks | Drug | CPG10101 + pegylated interferon |
| CPG10101CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Ribavirin, oral, 800-1400mg, daily, 12wks | Drug | CPG10101 + ribavirin |
| CPG10101CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks | Drug | CPG10101 + pegylated interferon + ribavirin |
| ControlPegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks | Drug | Pegylated inteferon + ribavirin |
| CPG10101CPG10101, subcutaneous, 0.20mg/kg, weekly, 12wks Pegylated Interferon alfa-2b, subcutaneous, 1.5ug/kg, weekly, 12wks Ribavirin, oral, 800-1400mg (weight-based), daily, 12wks | Drug | CPG10101 + pegylated interferon + ribavirin (rollover) |
Primary outcome
Adverse events, vital signs, clinical and laboratory parameters, physical exam, ECG
Time frame: 16wks
1 secondary outcome
Serum HCV RNA concentrations: Serum HCV concentrations over time to baseline
Time frame: 12wks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2011.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CPG10101 in people with Hepatitis, Chronic Active, run by Pfizer at 13 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 11 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 16 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Adverse events, vital signs, clinical and laboratory parameters, physical exam, ECG (time frame: 16wks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2011.