An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000178-21-PL

Enrollment

200

Registered

2007-09-04

Start date

Unknown

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1 Level: LLT Classification code 10011765 Term: Cystic fibrosis pancreas

Interventions

Product Name: ALTU-135 Product Code: ALTU-135 Pharmaceutical Form: Capsule* INN or Proposed INN: NA CAS Number: 9001-62-1 Other descriptive name: Lipase CLEC Concentration unit: U unit(s) Concentrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: = 7 years of age 2. Females of childbearing potential must be willing to use birth control (IUD; oral, transdermal or parenteral contraceptives; abstinence) 3. Diagnosis of CF based upon the following criteria: a. two clinical features consistent with CF; and either ? A genotype with two identifiable mutations consistent with CF, or ? Sweat chloride > 60 mEq/l by quantitative pilocarpine iontophoresis 4. Clinically stable with no evidence of acute upper or lower respiratory tract infection 5. PI determined by fecal elastase =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. 5 x ULN, or total bilirubin level > 1.5x ULN at the Screening Visit or at Baseline (except for patients with Gilbert Syndrome) 8. Signs and/or symptoms of liver cirrhosis or portal hypertension (e.g., splenomegaly, ascites, esophageal varices), or documented liver disease unrelated to CF 9. Unable to discontinue enteral tube feedings during the study 10. Any condition that the Investigator believes would interfere with the intent of this study or would make participation not in the best interest of the patient. 11. Baseline CFA = 93% from the Phase III efficacy study (Protocol 0000726) 12. Patient is unlikely to complete the study, as determined by the Investigator

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the long-term safety and tolerability of ALTU-135 treatment in patients with Cystic Fibrosis related exocrine Pancreatic Insufficiency;Secondary Objective: ;Primary end point(s): To evaluate the long-term safety and tolerability of ALTU-135 treatment in patients with CYstic Fibrosis related exocrine Pancretic Insufficiency	—

Countries

Italy, Poland, Slovakia

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026