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Chronic Hepatitis CPhase 3NCT01890200

The Effects of Adding TCM-700C on the Standard Combination Treatment for HCV Genotype 1 Patients(Phase III)

A Phase 3 study testing Peginterferon alfa-2a, Ribavirin and TCM-700C in people with Chronic Hepatitis C, run by TCM Biotech International Corp. at 2 sites in 2 countries.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection. 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?
Peginterferon alfa-2a, Ribavirin and TCM-700C
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
2 sitesin 2 countries
Study dates
Jun 2015to Jun 2018
Phase
Phase 3
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 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult subjects who are 20 to 65 years old (inclusive), of either gender and in any ethnical group in Asia.
  • Chronic hepatitis C, positive with both antibody to hepatitis C virus (anti HCV) and HCV RNA assays.
  • Confirmed HCV genotype 1.
  • Subjects who are indicated to have combination treatment of PegIFNα 2a and RBV at the discretion of the investigator.
  • All fertile males and females receiving RBV must be using two forms of effective contraception during treatment with study drugs and 6 months post treatment completion.
  • Subjects must voluntarily give written informed consent indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.
  • Subjects must be able to comply with the assessments during the study.
  • Subjects must be able to understand study QoL questionnaires.

Who cannot join

  • Prior treatment with any IFN α or any medicines that contain Cordyceps.
  • Prior treatment of hepatitis C with any other antiviral or immune modulators.
  • Investigational therapy administered within 4 weeks, or within a time interval less than at least 5 half lives of the investigational agent, whichever is longer, prior to the first scheduled day of dosing in this study.
  • Subjects diagnosed with hepatocellular carcinoma (HCC) by biopsy or α fetoprotein (AFP) serology and radiology (helical computed tomography [CT] and/or magnetic resonance imaging [MRI]) within 5 years of signing the informed consent form.
  • Evidence of hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy).
  • History or evidence of other liver diseases other than chronic HCV infection.
Show all 24Show fewer
  • Subjects with known allergy or hypersensitivity to any ingredient of the study drug or placebo.
  • Pregnant, planning on becoming pregnant, or breastfeeding female subject or male subject whose partner is pregnant or planning on becoming pregnant.
  • Subject with any of the following laboratory abnormalities:
  • Platelet count <90,000/mm3;
  • Absolute neutrophil count <1500 cells/mm3;
  • Hemoglobin <12 g/dL for women and <13 g/dL for men;
  • Creatinine >1.5 mg/dL;
  • Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >10 x upper limit of normal (ULN);
  • Total serum bilirubin >1.5 x ULN;
  • Subjects without cirrhosis and AFP >50 ng/mL must have an ultrasound between the screening and baseline visit with no findings suspicious for HCC.
  • Medical conditions which are contraindications for PegIFNα 2a or RBV therapy:
  • Psychiatric disorders;
  • Organ transplant (other than cornea or hair transplant or skin graft);
  • Severe concurrent medical disease such as severe hypertension, significant coronary heart disease, poorly controlled diabetes mellitus (glycated hemoglobin A1c [HbA1c] >8.5%), not adequately controlled thyroid dysfunction, chronic obstructive pulmonary disease, severe infections (bacterial, viral, fungal, including acute tuberculosis), or hemoglobinopathies (thalassemia major or sickle cell anemia);
  • Autoimmune hepatitis or other autoimmune conditions known to be exacerbated by PegIFNα 2a and RBV.
  • History of a severe seizure disorder or current anticonvulsant use.
  • Evidence of severe retinopathy (e.g., cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (e.g., due to diabetes mellitus or hypertension).
  • Other cases judged by the investigator to be ineligible for participation in the study.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

China1 site

  • Peking University People's Hospit

    Beijing, Beijing Municipality, 100044

Other trials in China

Taiwan1 site

  • Chang Gung Memorial Hospital

    Taoyuan, 333

Other trials in Taiwan

About this study

Official title: A Phase III, Randomized, Double Blind, Placebo Controlled Study to Evaluate the Effects of Adding TCM-700C,Botanical Drug, on the Standard Treatment (Peginterferon and Ribavirin) for Subjects With Naive Genotype 1 Hepatitis C Infection

This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection.

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 combination treatment, compared with the placebo add-on.

Read the detailed description

Eligible subjects with written informed consent will be stratified according to their baseline HCV RNA (≤800,000 IU/mL versus>800,000 IU/mL), stage of liver fibrosis (METAVIR system fibrosis score of 0 1 versus 2 3).

During the 48 week Treatment Period and 24 week Follow up Period, subjects will be assessed at regular intervals for efficacy and safety at Weeks 2, 4, 8, 12, 16 and then every 8 weeks thereafter until study completion. If possible, subjects who prematurely discontinue the study during the Treatment Period will have samples taken for hematology, biochemistry and urinalysis in the same week of discontinuation as well as 24 weeks after discontinuation.

Being tested
Peginterferon alfa-2a, Ribavirin, TCM-700C, Placebo
Keywords
add-on treatment, botanical drug, HCV genotype 1, TCM-700C
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.

  • Peginterferon alfa-2aDrug

    Also called Pegasys

    conventional treatment of Hepatitis C

  • RibavirinDrug

    Also called Rebetol

    conventional treatment of Hepatitis C

  • TCM-700CDrug

    An add-on drug to conventional treatment of Hepatitis C

  • PlaceboDrug

    Also called Placebo, without acting ingredient.

    Placebo, without acting ingredient.

Study groups in NCT01890200
Study groupRoleWhat they receive
TCM-700C (low dose)Experimentalan add-on drug (t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: TCM-700C
TCM-700C (high dose)Experimentalan add-on drug (t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C
Receives: Drug: Peginterferon alfa-2a; Drug: Ribavirin; Drug: TCM-700C
PlaceboPlacebo comparatorplacebo add on(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.

  1. sustained virologic response (SVR) rate

    undetectable HCV RNA 24 weeks after the EOT.

    Measured: 24 weeks after the end of treatment (EOT, 48 weeks)

Secondary outcomes (2)

  1. Virologic response (VR)

    undetectable HCV RNA at the EOT.

    Measured: at the EOT (48 weeks)

  2. relapse rate

    undetectable HCV RNA at the EOT followed by a positive HCV RNA level within 24 weeks after the EOT

    Measured: 24 weeks after the EOT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2013 (estimated)
  2. Study startJun 2015
  3. Primary completionMar 2018 (estimated)
  4. Study completionJun 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01890200
Sponsor's protocol ID
TCM-700-02-01
Status last verified
Jan 2016
First submitted
26 Jun 2013
Last updated
28 Apr 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Peginterferon alfa-2a, Ribavirin and TCM-700C in people with Chronic Hepatitis C, run by TCM Biotech International Corp. at 2 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 8 inclusion and 24 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: withdrawn, as of the sponsor's last update on 28 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 withdrawn before enrolling participants, so there are no results.

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) rate (time frame: 24 weeks after the end of treatment (EOT, 48 weeks)). 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 NCT01890200.

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 28 Apr 2017.

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