Chronic Hepatitis CPhase 2TCM-700CNCT00556504
The Effects of Adding TCM-700C on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
A Phase 2 study testing TCM-700C, Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by TCM Biotech International Corp. at 1 site in Taiwan.
Trial summary
The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients with genotype 1 chronic hepatitis C infections. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- TCM-700C, Peginterferon alfa-2a and Ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2007to May 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV strain confirmed as genotype I;
- Elevated ALT (≥1.5 x upper limit of normal)during last 6 months
- Females of childbearing potential with a negative serum pregnancy test
- Subject must be willing to sign a written informed consent
- Subject must be willing and able to adhere to dose and visit schedule.
Who cannot join
- Serum AFP levels > 400 ng/ml
- Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score of 3-4, or hepatocellular carcinoma (HCC);
- Co-infection with hepatitis B virus (HBV);
- Anti-HIV positive;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TCM-700C Phase II Trial The Effects of Adding a Chinese Formulation (TCM-700C) on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment, compared with the placebo add-on.
Read the detailed description
This was a randomized, double-blind, placebo controlled, parallel-group, Phase 2 study to evaluate the effects of adding a Chinese formulation (TCM-700C) on the standard combination treatment for patients with Genotype 1 hepatitis C infection. Patients were screened within 4 weeks before receive the first study drug dose. Eligible patients at baseline were stratified according to baseline HCV RNA (≤800,000 IU/ml vs >800,000 IU/ml) and randomized with an equal chance to receive either TCM-700C or placebo as an add-on to the combination drug therapy. The combination drug therapy was peginterferon α-2b (PEG-INTRON®, Schering-Plough) 1.5 micrograms/kg once weekly injection for 48 weeks plus oral ribavirin (REBETOL®, Shering-Plough) 1000mg-1200mg daily for 48 weeks. The add-on treatment of TCM-700C or placebo was given 2 tablets thrice daily for 48 weeks.
During the 48 week treatment period and 24 week untreated follow-up, patients were assessed at regular intervals for safety and efficacy at weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. Patients who prematurely discontinued test drug therapy had laboratory examination re-taken on the week patient was discontinued from study.
- Conditions
- Chronic Hepatitis C
- Being tested
- TCM-700C, Peginterferon alfa-2a, Ribavirin, Placebo
- Keywords
- add-on treatment, botanical drug, HCV genotype 1, TCM-700C, genotype I
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM-700CDrug
An add-on drug to conventional treatment of Hepatitis C
Peginterferon alfa-2aDrug
Also called Peg-INTRON, Schering-Plough
conventional treatment of Hepatitis C
RibavirinDrug
Also called Rebetol, Schering-Plough)
conventional treatment of Hepatitis C
PlaceboDrug
Placebo, without acting ingredient.
| Study group | Role | What they receive |
|---|---|---|
| TCM-700C | Experimental | an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C Receives: Drug: TCM-700C; Drug: Peginterferon alfa-2a; Drug: Ribavirin |
| Placebo | Placebo comparator | placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response (SVR)
SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment..
- A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72.
- If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value.
- If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable.
Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)
Measured: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Secondary outcomes (6)
Virologic Response
undetectable HCV RNA at the end of combination drug treatment
Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit).
Measured: at the end of combination drug treatment (up to 48 weeks)
ALT Response
An ALT response is defined as normalization of ALT at the end of combination drug treatment.
(ALT normalization is defined as ALT level decreases into within the normal range)
Measured: at the end of combination drug treatment (up to 48 weeks)
Sustained ALT Response
a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment.
Measured: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Combined ALT and Virologic Response
Combined ALT and virologic response at the end of combination drug treatment.
Measured: at the end of combination drug treatment (up to 48 weeks)
Immune Cell Normalization
Normalization of immune cells, CD4, CD8 and NK cells at the end of combination drug treatment
(Immune cell normalization is defined as return of CD4, CD8 and NK cells to normal range)
Measured: at the end of combination drug treatment (up to 48 weeks)
Immune Cell Normalization
Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment.
Measured: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2007 (estimated)
- Study startJul 2007
- Primary completionJan 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic Hepatitis CStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- TCM Biotech International Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- I-Sheen Sheen, MD, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556504
- Sponsor's protocol ID
- TCM-700-01-04
- Acronym
- TCM-700C
- Status last verified
- Jul 2014
- First submitted
- 8 Nov 2007
- Last updated
- 7 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TCM-700C Phase II Trial The Effects of Adding a Chinese Formulation (TCM-700C) on the Standard Combination Treatment for Patients With Genotype 1 Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT00556504
- Acronym / sponsor ID
- TCM-700C / TCM-700-01-04
- Conditions
- Chronic Hepatitis C
- Keywords
- add-on treatment, botanical drug, HCV genotype 1, TCM-700C, genotype I
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- TCM Biotech International Corp.Industry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Jan 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Nov 2007 (estimated)
- Results
- Posted 8 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the effectiveness of TCM-700C as an add-on treatment to the combination drug therapy (Peginterferon α-2b plus Ribavirin) for patients with genotype 1 chronic hepatitis C infections. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combinational drug treatment, compared with the placebo add-on.
Detailed description
This was a randomized, double-blind, placebo controlled, parallel-group, Phase 2 study to evaluate the effects of adding a Chinese formulation (TCM-700C) on the standard combination treatment for patients with Genotype 1 hepatitis C infection. Patients were screened within 4 weeks before receive the first study drug dose. Eligible patients at baseline were stratified according to baseline HCV RNA (≤800,000 IU/ml vs >800,000 IU/ml) and randomized with an equal chance to receive either TCM-700C or placebo as an add-on to the combination drug therapy. The combination drug therapy was peginterferon α-2b (PEG-INTRON®, Schering-Plough) 1.5 micrograms/kg once weekly injection for 48 weeks plus oral ribavirin (REBETOL®, Shering-Plough) 1000mg-1200mg daily for 48 weeks. The add-on treatment of TCM-700C or placebo was given 2 tablets thrice daily for 48 weeks.
During the 48 week treatment period and 24 week untreated follow-up, patients were assessed at regular intervals for safety and efficacy at weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. Patients who prematurely discontinued test drug therapy had laboratory examination re-taken on the week patient was discontinued from study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TCM-700C | Experimental | Drug: TCM-700C, Drug: Peginterferon alfa-2a, Drug: Ribavirinan add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C |
| Placebo | Placebo comparator | Drug: Peginterferon alfa-2a, Drug: Ribavirin, Drug: Placeboplacebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- HCV strain confirmed as genotype I;
- Elevated ALT (≥1.5 x upper limit of normal)during last 6 months
- Females of childbearing potential with a negative serum pregnancy test
- Subject must be willing to sign a written informed consent
- Subject must be willing and able to adhere to dose and visit schedule.
Key exclusion criteria (4 listed)
- Serum AFP levels > 400 ng/ml
- Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score of 3-4, or hepatocellular carcinoma (HCC);
- Co-infection with hepatitis B virus (HBV);
- Anti-HIV positive;
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 |
|---|---|---|
| TCM-700CAn add-on drug to conventional treatment of Hepatitis C | Drug | TCM-700C |
| Peginterferon alfa-2aAlso: Peg-INTRON, Schering-Ploughconventional treatment of Hepatitis C | Drug | Placebo, TCM-700C |
| RibavirinAlso: Rebetol, Schering-Plough)conventional treatment of Hepatitis C | Drug | Placebo, TCM-700C |
| PlaceboPlacebo, without acting ingredient. | Drug | Placebo |
Primary outcome
Sustained Virologic Response (SVR)
Time frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
SVR is defined as no detectable HCV RNA in serum of patient at Week 72, which is 24 weeks after the termination of combination drug treatment.. 1. A subject is a sustained responder at a given week, if the subject has negative HCV RNA at that week and all the subsequent weeks through Week 72. 2. If a patient has a missing value between visits, then the last non-missing HCV RNA is carried forward to fill in the missing value. 3. If the patient's HCV RNA at last visit, Week 72 is missing or above the limit of detection, then the patient is a non-responder, even if all the previous visits from baseline onwards were undetectable. Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit)
6 secondary outcomes
Virologic Response
Time frame: at the end of combination drug treatment (up to 48 weeks)
ALT Response
Time frame: at the end of combination drug treatment (up to 48 weeks)
Sustained ALT Response
Time frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Combined ALT and Virologic Response
Time frame: at the end of combination drug treatment (up to 48 weeks)
Immune Cell Normalization
Time frame: at the end of combination drug treatment (up to 48 weeks)
Immune Cell Normalization
Time frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
I-Sheen Sheen, MD principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TCM-700C, Peginterferon alfa-2a and Ribavirin in people with Chronic Hepatitis C, run by TCM Biotech International Corp. at 1 site in Taiwan.
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 5 inclusion and 4 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 7 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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 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?
Yes. Results are posted in the registry (first posted 8 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sustained Virologic Response (SVR) (time frame: 24 weeks after the termination of combinational drug treatment (up to 72 weeks)). 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 7 Aug 2014.