CirrhosisNCT04057326
A Study of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Patients With Cirrhosis and Malnutrition
A study testing Oryz-Aspergillus Enzyme and Pancreatin Tablet in people with Cirrhosis, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd..
Trial summary
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 2 groups, including Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Cirrhosis
- What is being tested?
- Oryz-Aspergillus Enzyme and Pancreatin Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- No sites listed yet
- Study dates
- 30 Aug 2019to 28 Mar 2021
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is range from 18 to 70 years old.
- Sex is not limited.
- Confirmed cirrhosis (pathologic or radiological rationale) with a mid-upper arm muscle circumference (MAMC) < 90% of the standard value.
- The subject or his family (guardians) agreed to participate in the study and signed the informed consent form.
- Note: MAMC formula: mid-arm muscle circumference (cm) = mid-arm circumference (cm) - 3.14 × triceps skinfoldthickness. Standard values: 25.3 cm for adult males and 23.2 cm for adult females.
Who cannot join
- Subjects will be excluded from the study if they meet any of the following criteria:
- Pregnant, lactating women or women who do not exclude the possibility of pregnancy;
- Total serum bilirubin ≥ 5 times the upper limit of normal;
- Serum creatinine ≥ 1.2 times the upper limit of normal;
- Prothrombin time ≥ 18 seconds;
- Those who have an allergy to Oryz-Aspergillus Enzyme and Pancreatin Tablet and their related ingredients;
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- Subjects who are not able to eat orally for any reason;
- Subjects with a history of previous intestinal obstruction;
- Subjects with acute abdominal pain within 2 months prior to the start of the study;
- Subjects with electrolyte (sodium, potassium, chlorine) disorders that cannot be corrected prior to the start of the study, if electrolyte (sodium, potassium, chlorine) disorders have occurred, have been corrected and stabilized for more than 1 month prior to the start of the study;
- Subjects with prior hepatic encephalitic stage II or higher;
- History of refractory ascites with moderate or higher ascites within 2 weeks prior to the start of the study;
- Subjects with symptoms of gastrointestinal bleeding such as melena and hematemesis within 2 weeks prior to the start of the study;
- Those who have used antibiotics within 2 weeks prior to the start of the study;
- Subjects who experienced other conditions that could affect the study: Subjects who had acquired or primary, secondary immune system conditions (except primary autoimmune liver disease) such as major cardiopulmonary disease, diabetes mellitus, tumors, HIV infection, and other conditions that required long-term hormonal therapy;
- Substance abuse: Alcohol abuse (80 g/day) for < 6 months with a history of intravenous or/and inhaled drugs (drugs) in the last two years;
- Subjects with chronic viral hepatitis B/C who started and/or adjusted their antiviral regimen within 6 months prior to the start of the study;
- Subjects with a history of surgery within 6 months prior to the start of the study;
- Subjects with autoimmune liver disease who started or adjusted their regimen within 6 months prior to the start of the study (i.e., subjects who have started treatment for the aetiology with no change in treatment regimen and drug dose in the new addition of ursodeoxycholic acid or hormones, immunosuppressants, etc., in June)
- Those who participated in other drug trials within 3 months prior to the start of the study;
- Any subject who is considered by the investigator to be unable to participate in the study.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study to Evaluate the Safety and Efficacy of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Improving Malnutrition in Patients With Cirrhosis
The investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 2 groups, including Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group). Treatment group includes 99 subjects, while control group includes 33 subjects. They receive investigational drug 2 tablets/times, tid, p.o. for 180 days.
Read the detailed description
- A total of 132 subjects with cirrhosis were divided into 3 subgroups by Child-Pugh score, which were Child-pugh Class A, B, and C, respectively. Each subgroup includes 44 subjects, which were randomly assigned to the Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group) in a ratio of 3: 1 (33: 11).
- Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the Oryz-Aspergillus Enzyme and Pancreatin tablet group or the placebo group. No matter which group the subjects is assigned, he/she would receive treatment drugs through oral administration for 180 days, during which the participant will not take any investigational drug.
- The differences in nutritional status between treatment group and control group will be compared in 90 and 180 days by MAMC and SGA.
- Conditions
- Cirrhosis
- Being tested
- Oryz-Aspergillus Enzyme and Pancreatin Tablet, Placebo
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oryz-Aspergillus Enzyme and Pancreatin TabletDrug
Also called Treatment Group :Combizym
2 tablets/time, 3 times daily,Oral Administration.
PlaceboDrug
Also called Control Group
2 tablets/time, 3 times daily,Oral Administration.
| Study group | Role | What they receive |
|---|---|---|
| Oryz-Aspergillus Enzyme and Pancreatin Tablet Arm | Active comparator | Oryz-Aspergillus Enzyme and Pancreatin Tablet ,2 tablets/time, 3 times daily. Study drug will be administered orally. Receives: Drug: Oryz-Aspergillus Enzyme and Pancreatin Tablet |
| Placebo Arm | Placebo comparator | Placebo,2 tablets/time, 3 timesdaily. Study drug will be administered orally. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Change in nutritional status by Mid-Arm Muscle Circumference (MAMC) evaluation, the unit of MAMC is centimeter(cm).
The change in nutritional status of subjects at 180 days was evaluated by MAMC. MAMC, as a marker of lean muscle mass, is calculated using the standard formula: MAMC = MAC-(3.14 x TSF thickness).
MAC: mid-arm circumference TSF : triceps skinfold thickness
Measured: 180 days
2. Change in nutritional status by Subjective Global Assessment (SGA) evaluation.
The change in nutritional status of subjects at 180 days was evaluated by SGA Form.
The nutritional status of the subjects was improved if any of the index reached the "effective" standard.
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start30 Aug 2019 (estimated)
- Primary completion30 Dec 2020 (estimated)
- Study completion28 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CirrhosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057326
- Sponsor's protocol ID
- Combizym-PEM-001
- Status last verified
- Aug 2019
- First submitted
- 2 Aug 2019
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Study to Evaluate the Safety and Efficacy of Oryz-Aspergillus Enzyme and Pancreatin Tablet in Improving Malnutrition in Patients With Cirrhosis
- ClinicalTrials.gov ID
- NCT04057326
- Acronym / sponsor ID
- Combizym-PEM-001
- Conditions
- Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Shenzhen Kangzhe Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Aug 2019 (estimated)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 28 Mar 2021 (estimated)
- First posted
- 15 Aug 2019 (actual)
- 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 investigation is a randomized, double-blind, placebo involved and multi-center clinical trial. All subjects are assigned to 2 groups, including Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group). Treatment group includes 99 subjects, while control group includes 33 subjects. They receive investigational drug 2 tablets/times, tid, p.o. for 180 days.
Detailed description
- A total of 132 subjects with cirrhosis were divided into 3 subgroups by Child-Pugh score, which were Child-pugh Class A, B, and C, respectively. Each subgroup includes 44 subjects, which were randomly assigned to the Oryz-Aspergillus Enzyme and Pancreatin tablet group (treatment group) and the placebo group (control group) in a ratio of 3: 1 (33: 11).
- Patients who have signed the Informed Consent Form and are eligible for the entry criteria will be randomly assigned to either the Oryz-Aspergillus Enzyme and Pancreatin tablet group or the placebo group. No matter which group the subjects is assigned, he/she would receive treatment drugs through oral administration for 180 days, during which the participant will not take any investigational drug.
- The differences in nutritional status between treatment group and control group will be compared in 90 and 180 days by MAMC and SGA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oryz-Aspergillus Enzyme and Pancreatin Tablet Arm | Active comparator | Drug: Oryz-Aspergillus Enzyme and Pancreatin TabletOryz-Aspergillus Enzyme and Pancreatin Tablet ,2 tablets/time, 3 times daily. Study drug will be administered orally. |
| Placebo Arm | Placebo comparator | Drug: PlaceboPlacebo,2 tablets/time, 3 timesdaily. Study drug will be administered orally. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The age is range from 18 to 70 years old.
- Sex is not limited.
- Confirmed cirrhosis (pathologic or radiological rationale) with a mid-upper arm muscle circumference (MAMC) < 90% of the standard value.
- The subject or his family (guardians) agreed to participate in the study and signed the informed consent form.
- Note: MAMC formula: mid-arm muscle circumference (cm) = mid-arm circumference (cm) - 3.14 × triceps skinfoldthickness. Standard values: 25.3 cm for adult males and 23.2 cm for adult females.
Key exclusion criteria (21 listed)
- Pregnant, lactating women or women who do not exclude the possibility of pregnancy;
- Total serum bilirubin ≥ 5 times the upper limit of normal;
- Serum creatinine ≥ 1.2 times the upper limit of normal;
- Prothrombin time ≥ 18 seconds;
- Those who have an allergy to Oryz-Aspergillus Enzyme and Pancreatin Tablet and their related ingredients;
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 |
|---|---|---|
| Oryz-Aspergillus Enzyme and Pancreatin TabletAlso: Treatment Group :Combizym2 tablets/time, 3 times daily,Oral Administration. | Drug | Oryz-Aspergillus Enzyme and Pancreatin Tablet Arm |
| PlaceboAlso: Control Group2 tablets/time, 3 times daily,Oral Administration. | Drug | Placebo Arm |
Primary outcome
1. Change in nutritional status by Mid-Arm Muscle Circumference (MAMC) evaluation, the unit of MAMC is centimeter(cm).
Time frame: 180 days
The change in nutritional status of subjects at 180 days was evaluated by MAMC. MAMC, as a marker of lean muscle mass, is calculated using the standard formula: MAMC = MAC-(3.14 x TSF thickness). MAC: mid-arm circumference TSF : triceps skinfold thickness
2. Change in nutritional status by Subjective Global Assessment (SGA) evaluation.
Time frame: 180 days
The change in nutritional status of subjects at 180 days was evaluated by SGA Form. The nutritional status of the subjects was improved if any of the index reached the "effective" standard.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Oryz-Aspergillus Enzyme and Pancreatin Tablet in people with Cirrhosis, run by Shenzhen Kangzhe Pharmaceutical Co., Ltd..
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 21 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: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
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?
1. Change in nutritional status by Mid-Arm Muscle Circumference (MAMC) evaluation, the unit of MAMC is centimeter(cm). (time frame: 180 days). The study lists 2 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 15 Aug 2019.