Status:
UNKNOWN
Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis
Lead Sponsor:
Inge Marie Svane
Conditions:
Hepatitis, Drug-Induced
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This clinical trial is to clarify and investigate the patterns of immune-related hepatitis and the optimal treatment choice for patients who are steroid-dependent. The project aims to prospectively ch...
Detailed Description
The number of patients treated with immune checkpoint inhibitors (ICI) is expanding worldwide due to an increasing number of indications, including additional types of cancer, combination of ICI with ...
Eligibility Criteria
Inclusion
- Cohort A:
- \- Abnormal liver parameters equal to ≥ grade 3 ir-hepatitis defined as; AST/ALT/ALP \>5 x ULN, INR ≥ 2.5 x ULN, or bilirubin \> 3.0 x ULN
- Cohort B:
- \- Patients who recur during or within one months of prednisolone tapering of ≥2 ir-hepatitis equal to AST/ALT ≥3 x ULN, ALP ≥2.5 x ULN, INR ≥ 1.5 x ULN, or bilirubin ≥ 3.0 x ULN
- Cohort A and Cohort B
- Histologically confirmed solid cancer
- Treatment with cytotoxic T-lymphocyte-associated protein-4 (CTLA-4) or Programmed Cell Death-1 (PD-1)/Programmed Cell Death Ligand-1 (PD-L1) inhibitor or a combination of CTLA-4 plus PD-1 inhibitors within 6 months
- Age: ≥ 18 years
- Women of childbearing potential: Negative serum pregnancy test and must use effective contraception. This applies from screening and until 6 months after treatment. Birth control pills, spiral, depot injection with gestagen, subdermal implantation, hormonal vaginal ring and transdermal depot patch are all considered effective contraceptives
- Men with female partner of childbearing potential must use effective contraception from screening and until 6 months after treatment. Effective contraceptives are as described above for the female partner. In addition, documented vasectomy and sterility or double barrier contraception are considered effective contraceptives
- Signed statement of consent after receiving oral and written study information
- Willingness to participate in the planned treatment and follow-up and capable of handling toxicities.
Exclusion
- Concomitant chemotherapy treatment or tyrosine kinases or angiogenesis inhibitors
- Concomitant immunosuppressive medication except prednisolone
- Patients with hepatocellular carcinoma
- Known hypersensitivity to one of the active drugs or excipients
- Uncontrolled infection
- Acute viral hepatitis
- Any medical condition that will interfere with patient compliance or safety
- Simultaneous treatment with other experimental drugs or other anticancer drugs
- Pregnant or breastfeeding females
- Phenylketonuria
Key Trial Info
Start Date :
April 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 7 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04810156
Start Date
April 7 2021
End Date
November 7 2025
Last Update
December 14 2022
Active Locations (5)
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1
Herlev University Hospital
Herlev, Copenhagen, Denmark, 2730
2
Aalborg University Hospital
Aalborg, Denmark, 9000
3
Aarhus University Hospital
Aarhus, Denmark, 8000
4
Rigshospitalet
Copenhagen, Denmark, 2100