Hepatitis C VirusPhase 1NCT01391117
TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + Ribavirin
A Phase 1 study testing TMC649128. and TMC649128 in people with Hepatitis C Virus, run by Tibotec BVBA at 3 sites in 2 countries.
Trial summary
The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) and antiviral activity of repeated doses of TMC649128 given… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- TMC649128. and TMC649128
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 3 sitesin 2 countries
- Study dates
- Jun 2011to Nov 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented chronic (> 6 months) genotype 1a or 1b Hepatitis C virus (HCV) infection
- Treatment-naive volunteer, meaning never received (Peg)IFN, RBV or any other approved or investigational treatment for chronic HCV infection (Panels 1, 2, 3 or 4) OR volunteer is a documented prior non-responder or relapser subject to previous treatment regimens (IFN/RBV or pegylated IFN/RBV) but has stopped this treatment at least 6 months before screening
- volunteer has never received a HCV polymerase inhibitor and HCV protease inhibitor treatment was stopped since at least one year (Panels 1, 2 or 3)
- Volunteer with HCV plasma RNA levels of > 100,000 IU/mL at screening
- Body Mass Index of 18.0 to 35.0 kg/m2
- Healthy based on a medical evaluation including medical history, physical examination, blood tests, vital signs, and electrocardiogram.
Who cannot join
- Evidence of liver cirrhosis
- Historical liver biopsy graded as liver cirrhosis or evidence for the presence of oesophageal varices or a transient elastography (Fibroscan) result of more than 14.6 kPa within 2 years prior to screening
- Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices
- Evidence of renal dysfunction, documented by an estimated creatinine clearance below 70 mL/min
- Evidence of any other cause of significant liver disease in addition to hepatitis C, this may include but is not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis
- Volunteer with diagnosed or suspected hepatocellular carcinoma
- Volunteer receiving or having received any treatment for HCV during the 6 months before screening
- Volunteer coinfected with Human Immunodeficiency Virus-1 (HIV-1) or HIV-2, or hepatitis A or B virus infection, or clinically active tuberculosis at study screening.
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
About this study
Official title: A Phase Ib, Double-Blind, Randomized, Placebo-Controlled Trial in Genotype 1 HCV-Infected Subjects to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Repeated Doses of TMC649128 Given as Monotherapy and Given in Combination With Pegylated Interferon + Ribavirin
The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin. We assess the pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD) relationship for antiviral activity, active metabolite and safety of TMC649128 and its metabolites. We determine the short term safety and tolerability of the co-administration of TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We also assess in a preliminary way the short term antiviral effect of the combination of TMC649128 with pegylated interferon + ribavirin during a 14-day dosing period in treatment-naive genotype 1 HCV-infected participants.
Read the detailed description
TMC649128 is a nucleoside inhibitor (NI) of hepatitis C virus (HCV) polymerase in development for the treatment of chronic hepatitis C infection. Treatment-naive genotype 1 HCV-infected participants are participants who have never received (pegylated) interferon ([Peg]IFN), ribavirin (RBV) or any other approved or investigational treatment for chronic HCV infection. Treatment-experienced genotype 1 HCV-infected participants are defined as previous non-responder and relapse subjects to previous treatment regimens (IFN/RBV or PegIFN/RBV), who have never received a HCV polymerase inhibitor and HCV protease inhibitor treatment was stopped since at least one year. This study is a Phase Ib, double-blind, randomized, placebo-controlled trial in genotype 1 HCV-infected participants to determine the safety, tolerability, pharmacokinetics and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin. This trial consists of 2 phases. In the first phase TMC649128 will be given as monotherapy during 10 days at different doses and dosing regimens. In the second phase TMC649128 will be administered at one selected dose regimen in combination with PegIFN a-2a/RBV for 14 days.; All dosages of TMC649128 or placebo are given orally under fed conditions.; The monotherapy phase includes 3 panels (panel 1-3) and the combination therapy phase includes 1 panel (panel 4). In panel 1, subjects are randomly assigned to receive TMC649128 at 1000 mg q24h (every 24h) (n=8) or placebo (n=2) q24h on Days 1-10. In panel 2 subjects are randomized into Arm 1 and Arm 2 and within each arm, subjects are randomly assigned to receive TMC649128 or placebo as follows: In arm 1 volunteers receive TMC649128 at a selected dose (n=8) or placebo (n=2) q12h on Days 1-10. In arm 2 volunteers receive TMC649128 at a selected dose (n=8) or placebo (n=2) q24h on Days 1-10. Panel 3: TMC649128 at a selected dose (n=8) or placebo (n=2) q12h (every 12h) OR q24h on Days 1-10 where the assignment is determined by randomization; Panel 4 volunteers are randomized into Arm 1 and Arm 2. In panel 4, arm 1, 10 volunteers receive placebo (q12h OR q24h, dosing regimen matched to Arm 2 of Panel 4) + PegIFN a-2a/RBV on Days 1-14. In Panel 4, arm 2, 10 volunteers receive TMC649128 at a selected dose (q12h OR q24h) + PegIFN a-2a/RBV on Days 1-14.; The actual dose of Panel 1 is derived from data obtained from the currently ongoing MC649128HPC1001 trial. The actual dose in Panel 2 will depend on the results of Panel 1 (total daily dose of TMC649128 administered in both arms of Panel 2 will be the same. The dose of TMC649128 of the q24h regimen in Arm 2 will be higher than the q24h dose administered in Panel 1 [1000 mg q24h]). The actual doses and dose regimens in Panels 3 and 4 will depend on the results of Panels 1 and 2 (data review meetings). Selection of doses and dose regimens in Panels 2, 3 and 4 will also depend on the data obtained from trial TMC649128HPC1001. Dosing will stay within the exposure limits. The intended doses for Panels 2 and 3 are 2000 mg or 3000 mg q12h or q24h, but may be adapted based on previous clinical data. If needed and based on the outcome of the Panel 1 results, subjects in Panel 3 may eventually receive a lower dose than in Panel 1. See detailed study description.
- Conditions
- Hepatitis C Virus
- Being tested
- placebo., TMC649128., placebo, TMC649128
- Keywords
- TMC649128, HCV, TMC649128HPC1002, Hepatitis C, Hep C
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placebo.Drug
panel 1: 2 participants receive placebo at a q24h regimen.
placebo.Drug
panel 3: 2 participants receive placebo. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.
TMC649128.Drug
panel 2, arm 1: 8 participants receive a q12h regimen of TMC649128 at a selected dose based on results of panel 1.
placebo.Drug
panel 2, arm 2: 2 participants receive placebo at a q24h regimen.
placeboDrug
panel 4, arm 1: 10 participants receive PegIFN a-2a/RBV in combination with placebo, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3.
TMC649128Drug
panel 4, arm 2: 10 participants receive PegIFN a-2a/RBV in combination with TMC649128, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3.
TMC649128.Drug
panel 2, arm 2: 8 participants receive a q24h regimen TMC649128 at a dose based on results of panel 1.
TMC649128Drug
panel 3: 8 participants receive TMC649128. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.
TMC649128.Drug
panel 1: 8 participants receive a q24h regimen at 1000 mg of TMC649128.
placebo.Drug
panel 2, arm 1: 2 participants receive placebo at a q12h regimen.
| Study group | Role | What they receive |
|---|---|---|
| 010 | Experimental | TMC649128 panel 4 arm 2: 10 participants receive PegIFN a-2a/RBV in combination with TMC649128 administered q12h or q24h for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1 2 and 3. Receives: Drug: TMC649128 |
| 001 | Experimental | TMC649128. panel 1: 8 participants receive a q24h regimen at 1000 mg of TMC649128. Receives: Drug: TMC649128. |
| 002 | Placebo comparator | placebo. panel 1: 2 participants receive placebo at a q24h regimen. Receives: Drug: placebo. |
| 003 | Experimental | TMC649128. panel 2 arm 1: 8 participants receive a q12h regimen of TMC649128 at a selected dose based on results of panel 1. Receives: Drug: TMC649128. |
| 004 | Placebo comparator | placebo. panel 2 arm 1: 2 participants receive placebo at a q12h regimen. Receives: Drug: placebo. |
| 005 | Experimental | TMC649128. panel 2 arm 2: 8 participants receive a q24h regimen TMC649128 at a dose based on results of panel 1. Receives: Drug: TMC649128. |
| 006 | Placebo comparator | placebo. panel 2 arm 2: 2 participants receive placebo at a q24h regimen. Receives: Drug: placebo. |
| 007 | Experimental | TMC649128 panel 3: 8 participants receive TMC649128. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2. Receives: Drug: TMC649128 |
| 008 | Placebo comparator | placebo. panel 3: 2 participants receive placebo. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2. Receives: Drug: placebo. |
| 009 | Placebo comparator | placebo panel 4 arm 1: 10 participants receive PegIFN a-2a/RBV in combination with placebo administered q12h or q24h for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1 2 and 3. Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the steady-state plasma concentrations of TMC649128.
Measured: From baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3).
Change in the steady-state plasma concentrations of TMC649128 following co-administration with pegylated interferon + ribavirin.
Measured: From baseline up to day 84 (panel 4).
Viral load decreases and/or changes of viral load from baseline (HCV RNA copies/ml) (PK/PD).
Measured: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4).
Number of participants with adverse events as a measure of safety and tolerability - TMC649128 as monotherapy and when co-administered with pegylated interferon + ribavirin.
Measured: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4).
Secondary outcomes (2)
Antiviral activity (HCV RNA levels) of TMC649128 as monotherapy and when co-administered with pegylated interferon + ribavirin.
Measured: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4)
Antiviral activity (viral breakthrough) of TMC649128 as monotherapy and when co-administered with pegylated interferon + ribavirin.
Measured: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Antiviral activity was considered insufficient to warrant further clinical development of TMC649128.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tibotec BVBA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tibotec-Virco Virology BVBA Clinical Trial, Study director, Tibotec BVBA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391117
- Sponsor's protocol ID
- CR017992
- Other IDs
- TMC649128HPC1002
- Status last verified
- Oct 2012
- First submitted
- 13 Jun 2011
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Double-Blind, Randomized, Placebo-Controlled Trial in Genotype 1 HCV-Infected Subjects to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of Repeated Doses of TMC649128 Given as Monotherapy and Given in Combination With Pegylated Interferon + Ribavirin
- ClinicalTrials.gov ID
- NCT01391117
- Acronym / sponsor ID
- CR017992
- Conditions
- Hepatitis C Virus
- Keywords
- TMC649128, HCV, TMC649128HPC1002, Hepatitis C, Hep C
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Antiviral activity was considered insufficient to warrant further clinical development of TMC649128.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Tibotec BVBAIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 11 Jul 2011 (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 in genotype 1 Hepatitis C Virus (HCV)-infected participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin. We assess the pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD) relationship for antiviral activity, active metabolite and safety of TMC649128 and its metabolites. We determine the short term safety and tolerability of the co-administration of TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We also assess in a preliminary way the short term antiviral effect of the combination of TMC649128 with pegylated interferon + ribavirin during a 14-day dosing period in treatment-naive genotype 1 HCV-infected participants.
Detailed description
TMC649128 is a nucleoside inhibitor (NI) of hepatitis C virus (HCV) polymerase in development for the treatment of chronic hepatitis C infection. Treatment-naive genotype 1 HCV-infected participants are participants who have never received (pegylated) interferon ([Peg]IFN), ribavirin (RBV) or any other approved or investigational treatment for chronic HCV infection. Treatment-experienced genotype 1 HCV-infected participants are defined as previous non-responder and relapse subjects to previous treatment regimens (IFN/RBV or PegIFN/RBV), who have never received a HCV polymerase inhibitor and HCV protease inhibitor treatment was stopped since at least one year. This study is a Phase Ib, double-blind, randomized, placebo-controlled trial in genotype 1 HCV-infected participants to determine the safety, tolerability, pharmacokinetics and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin. This trial consists of 2 phases. In the first phase TMC649128 will be given as monotherapy during 10 days at different doses and dosing regimens. In the second phase TMC649128 will be administered at one selected dose regimen in combination with PegIFN a-2a/RBV for 14 days.; All dosages of TMC649128 or placebo are given orally under fed conditions.; The monotherapy phase includes 3 panels (panel 1-3) and the combination therapy phase includes 1 panel (panel 4). In panel 1, subjects are randomly assigned to receive TMC649128 at 1000 mg q24h (every 24h) (n=8) or placebo (n=2) q24h on Days 1-10. In panel 2 subjects are randomized into Arm 1 and Arm 2 and within each arm, subjects are randomly assigned to receive TMC649128 or placebo as follows: In arm 1 volunteers receive TMC649128 at a selected dose (n=8) or placebo (n=2) q12h on Days 1-10. In arm 2 volunteers receive TMC649128 at a selected dose (n=8) or placebo (n=2) q24h on Days 1-10. Panel 3: TMC649128 at a selected dose (n=8) or placebo (n=2) q12h (every 12h) OR q24h on Days 1-10 where the assignment is determined by randomization; Panel 4 volunteers are randomized into Arm 1 and Arm 2. In panel 4, arm 1, 10 volunteers receive placebo (q12h OR q24h, dosing regimen matched to Arm 2 of Panel 4) + PegIFN a-2a/RBV on Days 1-14. In Panel 4, arm 2, 10 volunteers receive TMC649128 at a selected dose (q12h OR q24h) + PegIFN a-2a/RBV on Days 1-14.; The actual dose of Panel 1 is derived from data obtained from the currently ongoing MC649128HPC1001 trial. The actual dose in Panel 2 will depend on the results of Panel 1 (total daily dose of TMC649128 administered in both arms of Panel 2 will be the same. The dose of TMC649128 of the q24h regimen in Arm 2 will be higher than the q24h dose administered in Panel 1 [1000 mg q24h]). The actual doses and dose regimens in Panels 3 and 4 will depend on the results of Panels 1 and 2 (data review meetings). Selection of doses and dose regimens in Panels 2, 3 and 4 will also depend on the data obtained from trial TMC649128HPC1001. Dosing will stay within the exposure limits. The intended doses for Panels 2 and 3 are 2000 mg or 3000 mg q12h or q24h, but may be adapted based on previous clinical data. If needed and based on the outcome of the Panel 1 results, subjects in Panel 3 may eventually receive a lower dose than in Panel 1. See detailed study description.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 010 | Experimental | Drug: TMC649128TMC649128 panel 4 arm 2: 10 participants receive PegIFN a-2a/RBV in combination with TMC649128 administered q12h or q24h for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1 2 and 3. |
| 001 | Experimental | Drug: TMC649128.TMC649128. panel 1: 8 participants receive a q24h regimen at 1000 mg of TMC649128. |
| 002 | Placebo comparator | Drug: placebo.placebo. panel 1: 2 participants receive placebo at a q24h regimen. |
| 003 | Experimental | Drug: TMC649128.TMC649128. panel 2 arm 1: 8 participants receive a q12h regimen of TMC649128 at a selected dose based on results of panel 1. |
| 004 | Placebo comparator | Drug: placebo.placebo. panel 2 arm 1: 2 participants receive placebo at a q12h regimen. |
| 005 | Experimental | Drug: TMC649128.TMC649128. panel 2 arm 2: 8 participants receive a q24h regimen TMC649128 at a dose based on results of panel 1. |
| 006 | Placebo comparator | Drug: placebo.placebo. panel 2 arm 2: 2 participants receive placebo at a q24h regimen. |
| 007 | Experimental | Drug: TMC649128TMC649128 panel 3: 8 participants receive TMC649128. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2. |
| 008 | Placebo comparator | Drug: placebo.placebo. panel 3: 2 participants receive placebo. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2. |
| 009 | Placebo comparator | Drug: placeboplacebo panel 4 arm 1: 10 participants receive PegIFN a-2a/RBV in combination with placebo administered q12h or q24h for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1 2 and 3. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Documented chronic (> 6 months) genotype 1a or 1b Hepatitis C virus (HCV) infection
- Treatment-naive volunteer, meaning never received (Peg)IFN, RBV or any other approved or investigational treatment for chronic HCV infection (Panels 1, 2, 3 or 4) OR volunteer is a documented prior non-responder or relapser subject to previous treatment regimens (IFN/RBV or pegylated IFN/RBV) but has stopped this treatment at least 6 months before screening
- volunteer has never received a HCV polymerase inhibitor and HCV protease inhibitor treatment was stopped since at least one year (Panels 1, 2 or 3)
- Volunteer with HCV plasma RNA levels of > 100,000 IU/mL at screening
- Body Mass Index of 18.0 to 35.0 kg/m2
Key exclusion criteria (8 listed)
- Evidence of liver cirrhosis
- Historical liver biopsy graded as liver cirrhosis or evidence for the presence of oesophageal varices or a transient elastography (Fibroscan) result of more than 14.6 kPa within 2 years prior to screening
- Evidence of decompensated liver disease defined as prior history or current evidence of ascites, hepatic encephalopathy, bleeding oesophageal or gastric varices
- Evidence of renal dysfunction, documented by an estimated creatinine clearance below 70 mL/min
- Evidence of any other cause of significant liver disease in addition to hepatitis C, this may include but is not limited to hepatitis B, drug- or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, non-alcoholic steatohepatitis, or primary biliary cirrhosis
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 |
|---|---|---|
| placebo.panel 1: 2 participants receive placebo at a q24h regimen. | Drug | 002 |
| placebo.panel 3: 2 participants receive placebo. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2. | Drug | 008 |
| TMC649128.panel 2, arm 1: 8 participants receive a q12h regimen of TMC649128 at a selected dose based on results of panel 1. | Drug | 003 |
| placebo.panel 2, arm 2: 2 participants receive placebo at a q24h regimen. | Drug | 006 |
| placebopanel 4, arm 1: 10 participants receive PegIFN a-2a/RBV in combination with placebo, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3. | Drug | 009 |
| TMC649128panel 4, arm 2: 10 participants receive PegIFN a-2a/RBV in combination with TMC649128, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3. | Drug | 010 |
| TMC649128.panel 2, arm 2: 8 participants receive a q24h regimen TMC649128 at a dose based on results of panel 1. | Drug | 005 |
| TMC649128panel 3: 8 participants receive TMC649128. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2. | Drug | 007 |
| TMC649128.panel 1: 8 participants receive a q24h regimen at 1000 mg of TMC649128. | Drug | 001 |
| placebo.panel 2, arm 1: 2 participants receive placebo at a q12h regimen. | Drug | 004 |
Primary outcome
Change in the steady-state plasma concentrations of TMC649128.
Time frame: From baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3).
Change in the steady-state plasma concentrations of TMC649128 following co-administration with pegylated interferon + ribavirin.
Time frame: From baseline up to day 84 (panel 4).
Viral load decreases and/or changes of viral load from baseline (HCV RNA copies/ml) (PK/PD).
Time frame: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4).
Number of participants with adverse events as a measure of safety and tolerability - TMC649128 as monotherapy and when co-administered with pegylated interferon + ribavirin.
Time frame: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4).
2 secondary outcomes
Antiviral activity (HCV RNA levels) of TMC649128 as monotherapy and when co-administered with pegylated interferon + ribavirin.
Time frame: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4)
Antiviral activity (viral breakthrough) of TMC649128 as monotherapy and when co-administered with pegylated interferon + ribavirin.
Time frame: For monotherapy from baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3) and for combination therapy from baseline up to day 84 (panel 4).
Results and safety
The study was stopped early (reason given: Antiviral activity was considered insufficient to warrant further clinical development of TMC649128.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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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.
Tibotec-Virco Virology BVBA Clinical Trial study director
Tibotec BVBA
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TMC649128. and TMC649128 in people with Hepatitis C Virus, run by Tibotec BVBA at 3 sites in 2 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 8 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: stopped early, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Poland, Netherlands. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: Antiviral activity was considered insufficient to warrant further clinical development of TMC649128.). Results are not available in the source record.
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?
Change in the steady-state plasma concentrations of TMC649128. (time frame: From baseline up to Day 80 per panel (panel 1 + panel 2 + panel 3).). The study lists 4 primary outcomes in all. 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 26 Oct 2012.