Chronic Hepatitis bPhase 4MAGIC-101NCT03349008
Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B
A Phase 4 study testing Entecavir, Magnesium Isoglycyrrhizinate and Diammonium Glycyrrhizinate in people with Chronic Hepatitis b and Liver Inflammation, run by Cttq.
Trial summary
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis b, Liver Inflammation
- What is being tested?
- Entecavir, Magnesium Isoglycyrrhizinate and Diammonium Glycyrrhizinate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2017to 31 May 2020
- Phase
- Phase 4
- 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
- Hepatitis B surface antigen [HBsAg]-positive,
- Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody (HBeAb)-positive disease were eligible,
- Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum total bilirubin(TBIL)levels<2×ULN
Who cannot join
- Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus;
- Other forms of liver disease;
- More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against HBV, and therapy with any anti-HBV drug within 24 weeks prior to randomization;
- More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin;
- Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC);
- During the study patients were not allowed to use other medicines.
About this study
Official title: The Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection Followed by Diammonium Glycyrrhizinate Enteric-coated Capsules and Combined With Entecavir on the Treatment of Chronic Hepatitis B
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.
Read the detailed description
Chronic hepatitis B(HBV) has a high prevalence (>8%) in China. Entecavir, aguanosine analog, is a potent and selective inhibitor of HBV DNA polymerase.
Glycyrrhizin has been used for more than 30 years in the treatment of liver diseases in Asian countries, who can relieve necro-inflammatory and liver fibrosis or cirrhosis Recent study has shown that inflammation plays the important role in chronic HBV and fibrosis or cirrhosis disease progression, but antiviral therapy only may not reduce inflammation ideally. The addition of glycyrrhizin to entecavir in the treatment may slow disease progression in patients with chronic HBV and advanced fibrosis or cirrhosis.
- Conditions
- Chronic Hepatitis b, Liver Inflammation
- Being tested
- Entecavir, Magnesium Isoglycyrrhizinate, Diammonium Glycyrrhizinate, Magnesium Isoglycyrrhizinate Placebo, Diammonium Glycyrrhizinate Placebo
- Keywords
- necro-inflammatory, glycyrrhizin, entecavir, hepatic biological parameters, liver fibrosis
- Medical subject headings
- Hepatitis B, Chronic, Hepatitis, Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EntecavirDrug
Also called Entecavir Pill
Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based
Magnesium IsoglycyrrhizinateDrug
Also called Magnesium Isoglycyrrhizinate Injection
Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based
Diammonium GlycyrrhizinateDrug
Also called Diammonium Glycyrrhizinate Enteric-coated Capsules
Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based
Magnesium Isoglycyrrhizinate PlaceboDrug
Also called Magnesium Isoglycyrrhizinate Injection Placebo
Magnesium Isoglycyrrhizinate Injection Placebo
Diammonium Glycyrrhizinate PlaceboDrug
Also called Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Entecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo Receives: Drug: Entecavir; Drug: Magnesium Isoglycyrrhizinate Placebo; Drug: Diammonium Glycyrrhizinate Placebo |
| Experimental group | Experimental | Entecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate Receives: Drug: Entecavir; Drug: Magnesium Isoglycyrrhizinate; Drug: Diammonium Glycyrrhizinate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of ALT(Alanine aminotransferase)
The ALT levels of plasma are measured at baseline and at 24 weeks. The normal value was 0-40 U/L.
Measured: baseline and 24 weeks
Secondary outcomes (2)
Change of Liver inflammatory
Liver inflammatory of the liver biopsies is performed at baseline and 24 weeks evaluated by Knodell HAI score.
Measured: baseline and 24 weeks
Change of Liver Fibrosis
Liver Fibrosis is performed at baseline and 96 weeks evaluated by Fibroscan examination.
Measured: baseline and 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2017
- Study start25 Nov 2017 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis bStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cttq
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03349008
- Sponsor's protocol ID
- Cttq-MAGIC-101
- Acronym
- MAGIC-101
- Status last verified
- Nov 2017
- First submitted
- 4 May 2017
- Last updated
- 21 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Study of Magnesium Isoglycyrrhizinate Injection Followed by Diammonium Glycyrrhizinate Enteric-coated Capsules and Combined With Entecavir on the Treatment of Chronic Hepatitis B
- ClinicalTrials.gov ID
- NCT03349008
- Acronym / sponsor ID
- MAGIC-101 / Cttq-MAGIC-101
- Conditions
- Chronic Hepatitis b, Liver Inflammation
- Keywords
- necro-inflammatory, glycyrrhizin, entecavir, hepatic biological parameters, liver fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- CttqIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2017 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 21 Nov 2017 (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.
This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.
Detailed description
Chronic hepatitis B(HBV) has a high prevalence (>8%) in China. Entecavir, aguanosine analog, is a potent and selective inhibitor of HBV DNA polymerase.
Glycyrrhizin has been used for more than 30 years in the treatment of liver diseases in Asian countries, who can relieve necro-inflammatory and liver fibrosis or cirrhosis Recent study has shown that inflammation plays the important role in chronic HBV and fibrosis or cirrhosis disease progression, but antiviral therapy only may not reduce inflammation ideally. The addition of glycyrrhizin to entecavir in the treatment may slow disease progression in patients with chronic HBV and advanced fibrosis or cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Entecavir, Drug: Magnesium Isoglycyrrhizinate Placebo, Drug: Diammonium Glycyrrhizinate PlaceboEntecavir treatment with placebo, Magnesium Isoglycyrrhizinate placebo followed by Diammonium Glycyrrhizinate placebo |
| Experimental group | Experimental | Drug: Entecavir, Drug: Magnesium Isoglycyrrhizinate, Drug: Diammonium GlycyrrhizinateEntecavir combined with glycyrrhizin, Magnesium Isoglycyrrhizinate Injection followed by Diammonium Glycyrrhizinate |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Hepatitis B surface antigen [HBsAg]-positive,
- Either hepatitis B e antigen (HBeAg)-positive or HBeAgnegative/hepatitis B e antibody (HBeAb)-positive disease were eligible,
- Serum alanine aminotransferase (ALT) levels 3-10×the upper limit of normal (ULN),serum total bilirubin(TBIL)levels<2×ULN
Key exclusion criteria (6 listed)
- Co-infection with hepatitis C virus, hepatitis D virus, or human immunodeficiency virus;
- Other forms of liver disease;
- More than 24 weeks of therapy with a nucleoside or nucleotide analog with activity against HBV, and therapy with any anti-HBV drug within 24 weeks prior to randomization;
- More than 12 weeks of therapy with liver protectants, and therapy with glycyrrhizin;
- Has decompensated liver function or has a hint of hepatocellular carcinoma (HCC);
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 |
|---|---|---|
| EntecavirAlso: Entecavir PillGlycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based | Drug | Control group, Experimental group |
| Magnesium IsoglycyrrhizinateAlso: Magnesium Isoglycyrrhizinate InjectionMagnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based | Drug | Experimental group |
| Diammonium GlycyrrhizinateAlso: Diammonium Glycyrrhizinate Enteric-coated CapsulesDiammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based | Drug | Experimental group |
| Magnesium Isoglycyrrhizinate PlaceboAlso: Magnesium Isoglycyrrhizinate Injection PlaceboMagnesium Isoglycyrrhizinate Injection Placebo | Drug | Control group |
| Diammonium Glycyrrhizinate PlaceboAlso: Diammonium Glycyrrhizinate Enteric-coated Capsules PlaceboDiammonium Glycyrrhizinate Enteric-coated Capsules Placebo | Drug | Control group |
Primary outcome
Change of ALT(Alanine aminotransferase)
Time frame: baseline and 24 weeks
The ALT levels of plasma are measured at baseline and at 24 weeks. The normal value was 0-40 U/L.
2 secondary outcomes
Change of Liver inflammatory
Time frame: baseline and 24 weeks
Change of Liver Fibrosis
Time frame: baseline and 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2017.
- Individual participant dataSharing planned: Undecided
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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 Phase 4 study testing Entecavir, Magnesium Isoglycyrrhizinate and Diammonium Glycyrrhizinate in people with Chronic Hepatitis b and Liver Inflammation, run by Cttq.
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 3 inclusion and 6 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 21 Nov 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change of ALT(Alanine aminotransferase) (time frame: baseline and 24 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 21 Nov 2017.