HCV InfectionPhase 1NCT00623649
Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
A Phase 1 study testing VCH 916 in people with HCV Infection, run by Vertex Pharmaceuticals Incorporated at 5 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- HCV Infection
- What is being tested?
- VCH 916
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Nov 2007to Oct 2008
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females 18 to 60 years of age
- No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3
- Subject's liver disease is stable with ALT values < 5 X ULN
- Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening
- Documented HCV Genotype 1 chronic hepatitis C.
- Judged to be in good health on the basis of medical history and physical examination
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- All other hematology and clinical chemistry must be within normal limits or show no clinically significant abnormalities.
- Be treatment-naïve or experienced.
- For female subjects, must not be pregnant or breastfeeding and must be postmenopausal, surgically sterile, abstinent, or using two proven methods of birth control.
- Sexually active male subjects, must be practicing acceptable methods of contraception during the treatment period
- Female subjects of childbearing potential must have a negative serum ß-HCG pregnancy test at screening and a negative urine pregnancy test on Day 1 before the first dose of study drugs.
- Agree not to participate in other clinical trials for the duration of his/her participation in this clinical trial.
Who cannot join
- Be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
- Be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol.
- Have a Child-Pugh score > than 5.
- Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy.
- Have any cause of liver disease other than chronic hepatitis C-infection
- Active or malignant disease or suspicion or history of malignant disease within five previous years (except for adequately treated basal cell carcinoma).
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- Have clinically significant electrocardiogram abnormalities and/or cardiovascular dysfunction within the previous 6 months
- Have significant renal, pulmonary, gastrointestinal absorption, or neurological diseases, or neoplasia.
- Have a history of psychiatric disorders determined by the investigator to contraindicate therapy.
- Have uncontrolled Type 1 or Type II diabetes.
- Antinuclear antibody titer ≥1:320.
- Coinfection with hepatitis B and/or HIV 1 or HIV 2.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
The Liver INstitute at Methodist Dallas
Dallas, Texas, 75208
Alamo Medical Research
San Antonio, Texas, 78215
Canada2 sites
Royal Victoria Hospital
Montreal, Quebec, H3A 1A1
Ottawa Hospital - General Campus
Ottawa, Ontario, K1H 8L6
About this study
Official title: A Phase 1B, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.
The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.
- Conditions
- HCV Infection
- Being tested
- VCH 916, Placebo
- 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 916Drug
Dose escalation study with a full review of all safety data following each cohort.
PlaceboDrug
Dose escalation study with a full review of all safety data following each cohort.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | VCH-916 100 mg three times a day (t.i.d.) Receives: Drug: VCH 916; Drug: Placebo |
| Cohort 2 | Experimental | VCH-916 200 mg (t.i.d.) Receives: Drug: VCH 916; Drug: Placebo |
| Cohort 3 | Experimental | VCH-916 300 mg twice daily for three days Receives: Drug: VCH 916; Drug: Placebo |
| cohort 4 | Experimental | VCH-916 400 mg twice daily for three days Receives: Drug: VCH 916; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection.
Measured: Day 1 to Day 17 visits
Secondary outcomes (3)
To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.
Measured: Day 1 visit
To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults.
Measured: Day 1 to Day 4 visits
To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916.
Measured: Day 1 to Day 4 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study startNov 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCV InfectionStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vertex Pharmaceuticals Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ViroChem Pharma, Duke Clinical Research Institute
- Responsible party
- Sponsor
- Investigators
- John McHutchison, MD, Principal investigator, Duke Clinical Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623649
- Sponsor's protocol ID
- VCH 916-103
- Status last verified
- Feb 2014
- First submitted
- 14 Feb 2008
- Last updated
- 4 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1B, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.
- ClinicalTrials.gov ID
- NCT00623649
- Acronym / sponsor ID
- VCH 916-103
- Conditions
- HCV Infection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Vertex Pharmaceuticals IncorporatedIndustry (pharma, biotech, devices)
- Collaborators
- ViroChem Pharma, Duke Clinical Research Institute
- Study start
- Nov 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 26 Feb 2008 (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 determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: VCH 916, Drug: PlaceboVCH-916 100 mg three times a day (t.i.d.) |
| Cohort 2 | Experimental | Drug: VCH 916, Drug: PlaceboVCH-916 200 mg (t.i.d.) |
| Cohort 3 | Experimental | Drug: VCH 916, Drug: PlaceboVCH-916 300 mg twice daily for three days |
| cohort 4 | Experimental | Drug: VCH 916, Drug: PlaceboVCH-916 400 mg twice daily for three days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Males and females 18 to 60 years of age
- No evidence of cirrhosis or have liver fibrosis corresponding to Metavir Stages 0 to 3
- Subject's liver disease is stable with ALT values < 5 X ULN
- Serologic evidence of detectable plasma HCV-RNA of ≥ 100,000 IU/ml at screening
- Documented HCV Genotype 1 chronic hepatitis C.
Key exclusion criteria (12 listed)
- Be participating in any other clinical studies or have participated in another clinical trial within the last 30 days before study drug administration, or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).
- Be actively taking hard illicit drugs within 12 months prior to the screening visit or alcohol.
- Have a Child-Pugh score > than 5.
- Have evidence of liver cirrhosis including histological evidence of hepatic cirrhosis on any liver biopsy.
- Have any cause of liver disease other than chronic hepatitis C-infection
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 916Dose escalation study with a full review of all safety data following each cohort. | Drug | Cohort 1, Cohort 2, Cohort 3, cohort 4 |
| PlaceboDose escalation study with a full review of all safety data following each cohort. | Drug | Cohort 1, Cohort 2, Cohort 3, cohort 4 |
Primary outcome
The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection.
Time frame: Day 1 to Day 17 visits
3 secondary outcomes
To evaluate the pharmacokinetic (PK) profile of VCH-916 in HCV-infected adults.
Time frame: Day 1 visit
To establish the relationship between VCH-916 plasma levels and corresponding HCV RNA reduction with the administered dosages of VCH-916 in adults.
Time frame: Day 1 to Day 4 visits
To study the kinetics of plasma HCV RNA following treatment for up to three(3) days with VCH-916.
Time frame: Day 1 to Day 4 visits
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 4 Apr 2014.
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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.
John McHutchison, MD principal investigator
Duke Clinical Research Institute
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VCH 916 in people with HCV Infection, run by Vertex Pharmaceuticals Incorporated at 5 sites in 3 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 12 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 4 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada, 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 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?
The primary objective of this trial is to assess the antiviral activity, safety, and tolerability of VCH-916 monotherapy in adult subjects with chronic HCV-infection. (time frame: Day 1 to Day 17 visits). 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 4 Apr 2014.