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Hepatitis, Drug-Induced

Treatment Efficacy of Corticosteroids and Mycophenolate Mofetil in Patients With Immune Related Hepatitis

Sponsored by Inge Marie Svane

About this trial

Last updated 2 years ago

Study ID

AA2032

Status

Recruiting

Type

Interventional

Phase

Phase 2

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started 4 years ago

What is this trial about?

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 characterize the various histopathological, biochemical, and phenotypical liver injury patterns induced by immune checkpoint inhibitors and the treatment responses to corticosteroids. Furthermore, the effect of adding a second-line immunosuppressive drug, either MMF in steroid-refractory or steroid-dependent cases will be explored and compared.

What are the participation requirements?

Yes

Inclusion Criteria

- 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.
No

Exclusion Criteria

- 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

Locations

Location

Status

Recruiting
Recruiting
Recruiting
Recruiting
Not yet recruiting