Trial Outcomes & Findings for Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis (NCT NCT00854087)

Last Updated: 2021-05-19

Results Overview

Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

118 participants

Primary outcome timeframe

Baseline to Week 60

Results posted on

2021-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Fuzheng Huayu Pill with Fuzheng Huayu Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks.	Placebo Pill without Fuzheng Huayu (sugar pill) Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks.
Overall Study STARTED	59	59
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	19	19

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assess the Antifibrotic Activity of Fuzheng Huayu in Chronic Hepatitis C Patients With Hepatic Fibrosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fuzheng Huayu n=59 Participants Pill with Fuzheng Huayu Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks.	Placebo n=59 Participants Pill without Fuzheng Huayu (sugar pill) Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks.	Total n=118 Participants Total of all reporting groups
Age, Continuous	55.4 years STANDARD_DEVIATION 6.72 • n=99 Participants	55.1 years STANDARD_DEVIATION 8.61 • n=107 Participants	55.3 years STANDARD_DEVIATION 7.67 • n=206 Participants
Sex: Female, Male Female	25 Participants n=99 Participants	23 Participants n=107 Participants	48 Participants n=206 Participants
Sex: Female, Male Male	34 Participants n=99 Participants	36 Participants n=107 Participants	70 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=99 Participants	9 Participants n=107 Participants	14 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	54 Participants n=99 Participants	50 Participants n=107 Participants	104 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
HCV Genotypes 1	48 participants n=99 Participants	52 participants n=107 Participants	100 participants n=206 Participants
HCV Genotypes 2	4 participants n=99 Participants	1 participants n=107 Participants	5 participants n=206 Participants
HCV Genotypes 3	6 participants n=99 Participants	5 participants n=107 Participants	11 participants n=206 Participants
HCV Genotypes 4	1 participants n=99 Participants	0 participants n=107 Participants	1 participants n=206 Participants
HCV Genotypes Other	0 participants n=99 Participants	1 participants n=107 Participants	1 participants n=206 Participants

PRIMARY outcome

Timeframe: Baseline to Week 60

Population: Number of participants randomized and who received at least one dose of Fuzheng Huayu or Placebo.

Safety will be evaluated through the changes in vital signs, physical examinations, adverse events, concomitant medication assessments as well as laboratory tests.

Outcome measures

Outcome measures
Measure	Fuzheng Huayu n=59 Participants Pill with Fuzheng Huayu Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks.	Placebo n=59 Participants Pill without Fuzheng Huayu (sugar pill) Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks.
Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Number of participants who experienced at least one adverse event	55 Participants	55 Participants
Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Number of participants who experienced at least one adverse event related to study drug	42 Participants	38 Participants
Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Number of participants who experienced at least one serious adverse event	7 Participants	10 Participants
Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Number of participants who experienced at least one serious adverse event related to study drug	0 Participants	1 Participants
Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Number of participants who had worsening of white blood cell count from baseline to week 48	42 Participants	45 Participants
Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Number of participants who had worsening of Platelets count from baseline to week 48	42 Participants	45 Participants
Safety of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Number of participants who had worsening of liver enzymes from baseline to week 48	43 Participants	45 Participants

PRIMARY outcome

Timeframe: Baseline to Week 48

Population: Participants who at least took one dose of study drug (Fuzheng Huayu or Placebo), were more than 80% compliant with study drug and had a pre and post study drug biopsy with an evaluable Ishak fibrosis score. Participants had ALT \<300 and a BMI \<40.

Efficacy of Fuzheng Huayu treatment was assessed through the change in liver fibrosis stage from the assessment before (pre) and after (post) study drug. The liver fibrosis staging system used was the Ishak scale. The Ishak liver fibrosis score ranges from 0 indicating no fibrosis to 6 indicating cirrhosis. "Fibrosis improved" was defined as a lower post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 3 or lower. "Fibrosis did not change" was defined as having the same Ishak score before and after study drug assessments e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 4. "Fibrosis worsened" was defined as a higher post study drug Ishak score, by at least 1 point, from pre-study drug assessment of the liver fibrosis e.g. if a pre study drug Ishak score of 4 and then a post study drug Ishak score of 5 or higher.

Outcome measures

Outcome measures
Measure	Fuzheng Huayu n=38 Participants Pill with Fuzheng Huayu Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks.	Placebo n=43 Participants Pill without Fuzheng Huayu (sugar pill) Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks.
Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Fibrosis improved	9 participants	13 participants
Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Fibrosis did not change	18 participants	12 participants
Efficacy of Fuzheng Huayu Treatment in Chronic Hepatitis C Subjects Who Have Failed Prior Anti-HCV Therapy or Cannot Receive or Refused Interferon Based Therapy. Fibrosis worsened	11 participants	18 participants

Adverse Events

Fuzheng Huayu

Serious events: 7 serious events

Other events: 55 other events

Deaths: 0 deaths

Placebo

Serious events: 10 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Dr. Tarek Hassanein

SCTI Research Foundation

Phone: 6195220330

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Measure	Fuzheng Huayu n=59 participants at risk Pill with Fuzheng Huayu Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks.	Placebo n=59 participants at risk Pill without Fuzheng Huayu (sugar pill) Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks.
Respiratory, thoracic and mediastinal disorders Sinus Infection	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/59 • Study duration (screening through last study visit)	3.4% 2/59 • Number of events 2 • Study duration (screening through last study visit)
Vascular disorders Hypotension	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Gastrointestinal disorders Bowel Obstruction	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Gastrointestinal disorders Abdominal Pain	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Social circumstances Alcohol Rehabilitation	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
General disorders Atypical Chest Pain	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)	0.00% 0/59 • Study duration (screening through last study visit)
Injury, poisoning and procedural complications T-12 Compression	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Injury, poisoning and procedural complications Opiod Overdose	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)	0.00% 0/59 • Study duration (screening through last study visit)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pleomorphic Rhabdomyosarcoma	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)	0.00% 0/59 • Study duration (screening through last study visit)
Hepatobiliary disorders Cholecystitis	3.4% 2/59 • Number of events 2 • Study duration (screening through last study visit)	0.00% 0/59 • Study duration (screening through last study visit)
Musculoskeletal and connective tissue disorders Transverse Myelilitis	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Adenoma	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Infections and infestations Acute Hepatitis	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Metabolism and nutrition disorders Hypokalemia/Hyponatremia/Nausea/Vomiting	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)

Measure	Fuzheng Huayu n=59 participants at risk Pill with Fuzheng Huayu Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks.	Placebo n=59 participants at risk Pill without Fuzheng Huayu (sugar pill) Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks.
Gastrointestinal disorders Gastrointestinal disorders such as nausea	66.1% 39/59 • Number of events 84 • Study duration (screening through last study visit)	50.8% 30/59 • Number of events 75 • Study duration (screening through last study visit)
General disorders General disorders such as fatigue	45.8% 27/59 • Number of events 44 • Study duration (screening through last study visit)	35.6% 21/59 • Number of events 27 • Study duration (screening through last study visit)
Infections and infestations Infections such as urinary tract infection	40.7% 24/59 • Number of events 26 • Study duration (screening through last study visit)	33.9% 20/59 • Number of events 34 • Study duration (screening through last study visit)
Respiratory, thoracic and mediastinal disorders Respiratory such as cough	33.9% 20/59 • Number of events 36 • Study duration (screening through last study visit)	40.7% 24/59 • Number of events 58 • Study duration (screening through last study visit)
Nervous system disorders Nervous system disorders such as headache	33.9% 20/59 • Number of events 46 • Study duration (screening through last study visit)	35.6% 21/59 • Number of events 35 • Study duration (screening through last study visit)
Psychiatric disorders Psychiatric disorders such as depression	25.4% 15/59 • Number of events 20 • Study duration (screening through last study visit)	25.4% 15/59 • Number of events 23 • Study duration (screening through last study visit)
Skin and subcutaneous tissue disorders Skin and subcutaneous system disorders such as rash	23.7% 14/59 • Number of events 17 • Study duration (screening through last study visit)	22.0% 13/59 • Number of events 19 • Study duration (screening through last study visit)
Injury, poisoning and procedural complications Injury, posioning and procedural complications such as muscle strain	16.9% 10/59 • Number of events 11 • Study duration (screening through last study visit)	20.3% 12/59 • Number of events 14 • Study duration (screening through last study visit)
Investigations Investigations such as liver biopsy	10.2% 6/59 • Number of events 6 • Study duration (screening through last study visit)	13.6% 8/59 • Number of events 8 • Study duration (screening through last study visit)
Surgical and medical procedures Surgical and medical procedures such as knee surgery	10.2% 6/59 • Number of events 9 • Study duration (screening through last study visit)	13.6% 8/59 • Number of events 8 • Study duration (screening through last study visit)
Metabolism and nutrition disorders Metabolism and nutrition disorders such as decreased appetite	8.5% 5/59 • Number of events 8 • Study duration (screening through last study visit)	8.5% 5/59 • Number of events 6 • Study duration (screening through last study visit)
Renal and urinary disorders Renal and urinary disorders such as nocturia	11.9% 7/59 • Number of events 8 • Study duration (screening through last study visit)	3.4% 2/59 • Number of events 2 • Study duration (screening through last study visit)
Vascular disorders Vascular disorders such as hypertension	3.4% 2/59 • Number of events 2 • Study duration (screening through last study visit)	8.5% 5/59 • Number of events 7 • Study duration (screening through last study visit)
Cardiac disorders Cardiac disorders such as tachycardia	3.4% 2/59 • Number of events 2 • Study duration (screening through last study visit)	6.8% 4/59 • Number of events 4 • Study duration (screening through last study visit)
Eye disorders Eye disorders such as dry eye	5.1% 3/59 • Number of events 3 • Study duration (screening through last study visit)	5.1% 3/59 • Number of events 3 • Study duration (screening through last study visit)
Immune system disorders Immune system disorders such as rhinitis allergy	5.1% 3/59 • Number of events 3 • Study duration (screening through last study visit)	5.1% 3/59 • Number of events 3 • Study duration (screening through last study visit)
Ear and labyrinth disorders Ear disorders such as vertigo	5.1% 3/59 • Number of events 3 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms such as ovarian cysts	5.1% 3/59 • Number of events 3 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Reproductive system and breast disorders Reproductive system disorders such as erectile dysfunction	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)	3.4% 2/59 • Number of events 3 • Study duration (screening through last study visit)
Endocrine disorders Endocrine disorders (hypothyroidism)	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)
Hepatobiliary disorders Hepatobiliary disorders (acute cholecistitis)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)	0.00% 0/59 • Study duration (screening through last study visit)
Social circumstances Social circumstances (alcohol rehabilitation)	0.00% 0/59 • Study duration (screening through last study visit)	1.7% 1/59 • Number of events 1 • Study duration (screening through last study visit)