A Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 in Adults With Chronic Hepatitis B
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CRMA-1001.
- Who it may be relevant to
- Registry conditions: Chronic Hepaititis B. Basic parameters: 18 years — 64 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Hong Kong, New Zealand, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multi-Center, Phase 1/2, Open-Label, Single and Multiple Ascending Dose Study of CRMA-1001 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Adults With Chronic Hepatitis B
Overview
This is an open-label study with single- and multiple-ascending dose arms followed by a dose expansion arm. The primary objective of the study is to determine the safety and tolerability of CRMA-1001 in adult participants with Chronic Hepatitis B. In addition, the pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of CRMA-1001 will be evaluated. CRMA-1001 is an epigenetic gene therapy delivered via intravenous (IV) infusion. Up to four dose levels will be tested. Participants will receive a single or multiple doses of CRMA-1001 and will remain on antiviral therapy during the dosing process.
Interventions
- Genetic CRMA-1001
Epigenetic gene silencing therapy delivered by intravenous (IV) infusion
Primary outcome measures
- Safety and tolerability of single and multiple doses of CRMA-1001 [Time frame: 6 months]
Secondary outcome measures (12)
- Long-term safety of single and multiple doses of CRMA-1001 [Time frame: 60 Months]
- Pharmacokinetics of CRMA-1001 components (Cmax) [Time frame: 6 Months]
- Pharmacokinetics of CRMA-1001 components (Tmax) [Time frame: 6 Months]
- Pharmacokinetics of CRMA-1001 components (terminal clearance rate) [Time frame: 6 Months]
- Pharmacokinetics of CRMA-1001 components (Vd) [Time frame: 6 Months]
- To evaluate the immunogenicity of CRMA-1001 [Time frame: 6 Months]
- To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg) [Time frame: 6 Months]
- To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBs) [Time frame: 6 Months]
- To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBV DNA) [Time frame: 6 Months]
- To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBeAg) [Time frame: 6 Months]
- To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (anti-HBe) [Time frame: 6 Months]
- To evaluate the effect of CRMA-1001 on circulating HBV biomarkers (HBsAg) [Time frame: 60 Months]
Eligibility criteria
Inclusion criteria
- Male/Female, weight 45-150 kg, age 18-64, inclusive
- Diagnosed with Chronic Hepatitis B
- On oral antiviral therapy
- ALT and AST <= 1.5 x ULN
- Total bilirubin <= ULN
Exclusion criteria
- Significant hepatic fibrosis or cirrhosis
- Current or prior liver disease other than HBV
- Other protocol-defined inclusion/exclusion criteria may apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- Hospices Civils De Leon — Lyon
Hong Kong · 1 center
- Queen Mary Hospital, The University of Hong Kong — Hong Kong
New Zealand · 1 center
- New Zealand Clinical Research — Auckland
United Kingdom · 1 center
- King's College Hospital — London
Identifiers
NCT: NCT07200193 · CRMA-1001-101