CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
rhBSSLdrug
Likely dose
rhBSSL 170 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00743483
NCT00743483Phase 2Completed
CompareCT.gov

An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency

Swedish Orphan Biovitrum·interventional·Posted Aug 28, 2008·Updated Nov 18, 2014

In Brief

A Phase 2 clinical trial evaluating rhBSSL for Cystic Fibrosis and Exocrine Pancreatic Insufficiency. Completed, enrolled 15 participants across 4 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy in patients with cystic fibrosis and pancreatic insufficiency following treatment with BSSL

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCystic Fibrosis, Exocrine Pancreatic Insufficiency
CountriesNetherlands, Poland
Collaborators--

Timeline

Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 28, 2008
Enrollment StartAug 1, 2008
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.8 years ago

Interventions

rhBSSLdrug

oral suspension, 170 mg BSSL, 3 times daily for 5-6 days