Hepatitis CPhase 1/2NCT00911963
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
A Phase 1/2 study testing peginterferon alfa-2a and ribavirin in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 10 sites in 4 countries.
Trial summary
The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C
- What is being tested?
- peginterferon alfa-2a and ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 10 sitesin 4 countries
- Study dates
- Apr 2009to Sep 2012
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B)
- Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system)
- Plasma HCV RNA of 100,000 IU/ml
- HIV 1 and HIV2 ab seronegative
- Body Mass Index (BMI) ≤ 35 kg/m2 BMI
- Treatment Naive subjects
Who cannot join
- Contraindications to peginterferon or ribavirin therapy
- Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score > 5
- Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes
Trial locations and contacts
10 sites in 4 countries.
10 sites in 4 countries
United States4 sites
The liver institute at Methodist hospital
Dallas, Texas, 75203
Henry Ford Health Sytem
Detroit, Michigan, 48202
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, 30060
Alamo Medical Research
San Antonio, Texas, 78215
Canada3 sites
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Downtown ID Clinic/University of British Columbia
Vancouver, British Columbia, V6Z 2C7
John Buhler Research Centre
Winnipeg, Manitoba, R3E 3P4
Argentina2 sites
ACLIRES Argentina SRL
Buenos Aires
Hospital Universitario Austral
Buenos Aires
About this study
Official title: A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection
The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin.
The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.
- Conditions
- Hepatitis C
- Being tested
- VCH-222 or matching placebo, peginterferon alfa-2a, ribavirin
- Keywords
- VX-222
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VCH-222 or matching placeboDrug
Also called VCH-222 is also known as VX-222
capsule, oral, 4 doses once daily or twice daily, 3 days
VCH-222 or matching placeboDrug
Also called VCH-222 is also known as VX-222
capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
peginterferon alfa-2aBiological
subcutaneous injection, 180 μg, once weekly, 48 weeks
ribavirinDrug
tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | This will be a 4 dose escalation study comparing VCH-222 to placebo treatment. Receives: Drug: VCH-222 or matching placebo |
| Part B | Experimental | VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks Receives: Drug: VCH-222 or matching placebo; Biological: peginterferon alfa-2a; Drug: ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)
Measured: Daily for the first 3 days and at each study visit
To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)
Measured: Week 4 and Week 12
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)
Measured: Study visits throughout part B
Secondary outcomes (2)
To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)
Measured: Study visits throughout Part A
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)
Measured: Time points through Part B
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startApr 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Vertex Pharmaceuticals IncorporatedThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViroChem Pharma
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Vertex Pharmaceuticals Incorporated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911963
- Sponsor's protocol ID
- VCH-222-102
- Status last verified
- Feb 2014
- First submitted
- 29 May 2009
- Last updated
- 10 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang M, Zhang EZ, Ardzinski A, Tigges A, Davis A, Sullivan JC, Nelson M, Spanks J, Dorrian J, Nicolas O, Bartels DJ, Rao BG, Rijnbrand R, Kieffer TL. Genotypic and phenotypic analyses of hepatitis C virus variants observed in clinical studies of VX-222, a nonnucleoside NS5B polymerase inhibitor. Antimicrob Agents Chemother. 2014 Sep;58(9):5456-65. doi: 10.1128/AAC.03052-14. Epub 2014 Jun 30.
PubMed 24982088
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection
- ClinicalTrials.gov ID
- NCT00911963
- Acronym / sponsor ID
- VCH-222-102
- Conditions
- Hepatitis C
- Keywords
- VX-222
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- ViroChem Pharma
- Study start
- Apr 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 3 Jun 2009 (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.
The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin.
The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: VCH-222 or matching placeboThis will be a 4 dose escalation study comparing VCH-222 to placebo treatment. |
| Part B | Experimental | Drug: VCH-222 or matching placebo, Biological: peginterferon alfa-2a, Drug: ribavirinVCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B)
- Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system)
- Plasma HCV RNA of 100,000 IU/ml
- HIV 1 and HIV2 ab seronegative
- Body Mass Index (BMI) ≤ 35 kg/m2 BMI
Key exclusion criteria (3 listed)
- Contraindications to peginterferon or ribavirin therapy
- Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score > 5
- Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes
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 |
|---|---|---|
| VCH-222 or matching placeboAlso: VCH-222 is also known as VX-222capsule, oral, 4 doses once daily or twice daily, 3 days | Drug | Part A |
| VCH-222 or matching placeboAlso: VCH-222 is also known as VX-222capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks | Drug | Part B |
| peginterferon alfa-2asubcutaneous injection, 180 μg, once weekly, 48 weeks | Biological | Part B |
| ribavirintablet, oral, 1000-1200 mg daily based on body weight, 48 weeks | Drug | Part B |
Primary outcome
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A)
Time frame: Daily for the first 3 days and at each study visit
To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B)
Time frame: Week 4 and Week 12
Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B)
Time frame: Study visits throughout part B
2 secondary outcomes
To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A)
Time frame: Study visits throughout Part A
To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B)
Time frame: Time points through Part B
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 10 Mar 2014.
- Derived from this study: PubMed 24982088Jiang M, Zhang EZ, Ardzinski A, Tigges A, Davis A, Sullivan JC, Nelson M, Spanks J, Dorrian J, Nicolas O, Bartels DJ, Rao BG, Rijnbrand R, Kieffer TL. Genotypic and phenotypic analyses of hepatitis C virus variants observed in clinical studies of VX-222, a nonnucleoside NS5B polymerase inhibitor. Antimicrob Agents Chemother. 2014 Sep;58(9):5456-65. doi: 10.1128/AAC.03052-14. Epub 2014 Jun 30.
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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.
Medical Monitor study director
Vertex Pharmaceuticals Incorporated
10 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing peginterferon alfa-2a and ribavirin in people with Hepatitis C, run by Vertex Pharmaceuticals Incorporated at 10 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 6 inclusion and 3 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 10 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States, Canada, Argentina, 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 combined 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.
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?
To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A) (time frame: Daily for the first 3 days and at each study visit). The study lists 3 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 NCT00911963, 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 10 Mar 2014.