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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM-700C | Experimental | an add-on drug (2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C |
|
| Placebo | Placebo Comparator | placebo add on(2 tablets/t.i.d) to conventional treatment(Peginterferon alfa-2a + ribavirin) of Hepatitis C |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TCM-700C | Drug | An add-on drug to conventional treatment of Hepatitis C |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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..
Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) | 24 weeks after the termination of combinational drug treatment (up to 72 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | at the end of combination drug treatment (up to 48 weeks) |
| ALT Response |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| I-Sheen Sheen, MD | Chang Gung Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chang Gung Memorial Hospital | Taoyuan | Taiwan | 333 | Taiwan |
Not provided
recruitment period: 12 Months location: CGMH clinical ceters
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| ID | Title | Description |
|---|---|---|
| FG000 | TCM-700C | TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks. |
| FG001 | Placebo | Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| ID | Title | Description |
|---|---|---|
| BG000 | TCM-700C | TCM-700C, an add-on drug to conventional treatment of Hepatitis C |
| BG001 | Placebo | Placebo with convetional treatment for HCV patients |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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..
Serum HCV RNA will be tested using a commercially available real-time polymerase-chain-reaction (PCR) assay kit (Roche Cobas TaqMan HCV assay kit) | Posted | Number | Number of participants with SVR | 24 weeks after the termination of combinational drug treatment (up to 72 weeks) |
|
72 weeks
Adverse reactions are monitored in all patients who were enrolled and took the study drugs at least one time in the study.
one patient was excluded from safety population because did not meet the eligibility criteria and did not take any study medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | TCM-700C (Safety Population) | TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (11.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ya-Chun Wang, EVP/CSO | TCM Biotech International | 886-2-26581677 | 733 | yachunwang@tcmbio.com |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Peginterferon alfa-2a |
| Drug |
conventional treatment of Hepatitis C |
|
|
| Ribavirin | Drug | conventional treatment of Hepatitis C |
|
|
| Placebo | Drug | Placebo, without acting ingredient. |
|
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) |
| 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. | 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. | 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) | 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. | 24 weeks after the termination of combinational drug treatment (up to 72 weeks) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Fibrosis score | Liver biopsy within 12 months prior to study entry showed liver cirrhosis with METAVIR system fibrosis score 0 No fibrosis
| Number | participants |
|
TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C
TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks.
| OG001 | Placebo | Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks. |
|
|
| Secondary | 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). | Posted | Number | participants | at the end of combination drug treatment (up to 48 weeks) |
|
|
|
| Secondary | 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) | Posted | Number | participants | at the end of combination drug treatment (up to 48 weeks) |
|
|
|
| Secondary | Sustained ALT Response | a sustained ALT response is defined as sustained normalization of ALT 24 weeks after cessation of combination drug treatment. | Posted | Number | participants | 24 weeks after the termination of combinational drug treatment (up to 72 weeks) |
|
|
|
| Secondary | Combined ALT and Virologic Response | Combined ALT and virologic response at the end of combination drug treatment. | Posted | Number | participants | at the end of combination drug treatment (up to 48 weeks) |
|
|
|
| Secondary | 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) | Posted | Number | participants | at the end of combination drug treatment (up to 48 weeks) |
|
|
|
| Secondary | Immune Cell Normalization | Normalization of immune cells, CD4, CD8 and NK cells at 24 weeks after cessation of combination drug treatment. | Posted | Number | participants | 24 weeks after the termination of combinational drug treatment (up to 72 weeks) |
|
|
|
| 9 |
| 41 |
| 41 |
| 41 |
| EG001 | Placebo (Safety Population) | Placebo with convetional treatment(PegIFN plus RBV) for HCV patients | 6 | 42 | 40 | 42 |
| Urinary infection | Infections and infestations | Serious | Non-systematic Assessment |
|
| Fever/pain | General disorders | Serious | Systematic Assessment |
|
| block stools | Gastrointestinal disorders | Serious | Non-systematic Assessment |
|
| sinusitis | General disorders | Serious | Non-systematic Assessment |
|
| hearing impairment | Ear and labyrinth disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Rhinorhea | Endocrine disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| neuritic depression | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| lose weight | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Palpiations | Cardiac disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Deafness | Ear and labyrinth disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Goitre | Endocrine disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Conjunctivities | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dry Eye | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal distention | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Apthous stomatits | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hemorrhoids | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Irritable bowel syndrome | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Peptic ulcer | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Reflux esophagitis | Gastrointestinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Gallbladder polyp | Hepatobiliary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hepatic steatosis | Hepatobiliary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA (11.1) | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Edema peripheral | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (11.1) | Non-systematic Assessment |
|
| Blood uric acid increased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Hemoglobin decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Neutrophil count decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA (11.1) | Non-systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hyperuricaemi | Metabolism and nutrition disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Tenosynovitis | Musculoskeletal and connective tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Hypoesthesia | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Mood altered | Psychiatric disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Urinary incontinency | Renal and urinary disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Skin disorder | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (11.1) | Non-systematic Assessment |
|
Not provided
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| NK cells |
|
| NK cells |
|