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Tests treatment safety and results for Chronic Hepatitis D Infection
Official title A Phase III Study to Evaluate the Efficacy and Safety of Libevitug in Participants With Chronic HDV Infection (D-clear Study)
ClinicalTrials.gov ID: NCT07499544
What this study is testing
What is Libevitug 20 mg/kg?
Libevitug 20 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic hepatitis d infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an international, multicenter, randomized, controlled, open-label Phase III trial. It will evaluate the efficacy and safety of libevitug in participants with chronic HDV infection.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 70
You may be able to join if
- Willing to sign written informed consent;
- Chronic HDV history with at least 6 months;
- HDV RNA ≥500 IU/mL at screening;
- ALT \>1ULN and \<10×ULN;
- Able to communicate well and comply with protocol.
You likely can't join if
- Concomitant decompensated cirrhosis;
- Previous or current HCC or suspicion for HCC;
- Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused...
- Participants with active hepatitis C infection, or HIV infection;
- Alcohol abuse or drug addiction within 1 year;
- Participants have participated in other clinical trial within 1 month;
See the full eligibility criteria
- Willing to sign written informed consent;
- Chronic HDV history with at least 6 months;
- HDV RNA ≥500 IU/mL at screening;
- ALT \>1ULN and \<10×ULN;
- Able to communicate well and comply with protocol.
- Concomitant decompensated cirrhosis;
- Previous or current HCC or suspicion for HCC;
- Participants with history of alcoholic liver disease, nonalcoholic steatohepatitis or other clinically significant chronic liver diseases not caused by HDV/HBV;
- Participants with active hepatitis C infection, or HIV infection;
- Alcohol abuse or drug addiction within 1 year;
- Participants have participated in other clinical trial within 1 month;
- Pregnant, lactating women.
The study team makes the final eligibility decision.
Where it's taking place
- Changchun, Jilin, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Changchun, Jilin, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.