Norursodeoxycholic Acid in the Treatment of Primary Sclerosing Cholangitis (NUC-3)

Dr. Falk Pharma

Status and phase: Completed; Phase 2

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: Placebo; Drug: norUDCA

Study type: Interventional

Funder types: Industry

Identifiers

NCT01755507

NUC-3/PSC

Details and patient eligibility

About

Evaluation of the efficacy of different doses of nor UDCA vs. placebo for the treatment of Primary Sclerosing Cholangitis (PSC). Identification of optimal dose(s)for the treatment of PSC.

Full description

Double-blind, randomized, multi-center, placebo-controlled, comparative exploratory phase II-finding trial.The study will be conducted with four treatment groups in the form of a parallel-group comparison and will serve to compare oral treatment with either 500 mg/d, 1000 mg/d or 1500 mg/d norursodeoxycholic acid capsules vs. Placebo capsules for the treatment of PSC.

Enrollment: 159 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed Informed Consent
2. Verified diagnosis of PSC
3. PSC patients with or without IBD
4. Women of childbearing potential have to apply during the entire duration of the study a highly effective method of birth control.

Exclusion criteria

1. History or presence of other concomitant liver diseases
2. Treatment with UDCA within 8 weeks prior to baseline visit.
3. Child B/C liver cirrhosis
4. Total bilirubin > 3.0 mg/dl at screening or baseline.
5. Any relevant systemic disease
6. TSH>ULN at screening
7. any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder
8. Any active malignant disease
9. Known intolerance/hypersensitivity to study drug
10. Existing or intended pregnancy of brest feeding
11. Simultaneous participation in another clinical trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

159 participants in 4 patient groups, including a placebo group

B

Experimental group

Description:

norUDCA

Treatment:

Drug: norUDCA

C

Experimental group

Description:

norUDCA

Treatment:

Drug: norUDCA

placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

A

Experimental group

Description:

norUDCA

Treatment:

Drug: norUDCA