Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Special Investigation (All Cases) of LipaCreon in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427712
• Other study ID #: P12-893
• Status: Completed
• Start date: August 2011
• Est. completion date: March 2018

Study information

• Verified date: March 2022
• Source: Viatris Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients due to cystic fibrosis receiving the treatment with LipaCreon in order to evaluate the effective and safe use of LipaCreon.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 99 Years

Eligibility

Inclusion Criteria

• Patients who receive LipaCreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency due to cystic fibrosis

Exclusion Criteria

• Patients with a history of hypersensitivity to the ingredient of LipaCreon.

• Patients with a history of hypersensitivity to porcine protein

Related Conditions & MeSH terms

• Cystic Fibrosis
• Digestive System Diseases
• Exocrine Pancreatic Insufficiency
• Fibrosis
• Gastrointestinal Diseases
• Pancreatic Diseases

Intervention

Drug:
• Pancrelipase

Locations

Country	Name	City	State
Japan	Research facility ID ORG-000141	Aichi
Japan	Site reference ID/Investigator # 93736	Aichi
Japan	Site reference ID/Investigator # 96698	Aichi
Japan	Site reference ID/Investigator no. ORG-000842	Aichi
Japan	Site Reference ID/Investigator# 73813	Aichi
Japan	Research facility ORG-000972	Ehime
Japan	Mylan investigational site A	Hyogo
Japan	Site reference ID/Investigator # 93735	Ibaraki
Japan	Site Reference ID/Investigator# 88673	Ibaraki
Japan	Site Reference ID/Investigator# 65529	Ishikawa
Japan	Site Reference ID/Investigator# 65530	Kagawa
Japan	Site Reference ID/Investigator# 65527	Kagoshima
Japan	Mylan investigational site C	Kanagawa
Japan	Mylan investigational site B	Miyagi
Japan	Site Reference ID/Investigator# 65528	Miyagi
Japan	Research facility ID ORG-001138	Oita
Japan	Research facility ID ORG-000594	Osaka
Japan	Research facility ORG-000971	Shizuoka
Japan	Site reference ID/Investigator# 117495	Tochigi
Japan	Research facility no. ORG-001309	Tokyo
Japan	Site Reference ID/Investigator# 67122	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Mylan Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Adverse Drug Reaction	An adverse event (AE) was defined as any unfavourable or unintended disease, or symptom or sign of such a disease, or abnormal laboratory finding that occurred in a patient who received Lipacreon, whether or not considered related to the medicinal product. Also, an AE for which the relationship with Lipacreon could not be ruled out was regarded as an adverse drug reaction (ADR).; Related : There is a temporal relationship between the use of the medicinal product and the onset of an AE, or a relapse with readministration,where other factors are less likely to be involved.; Relationship cannot be ruled out : There are other potential factors although there is a temporal relationship between the use of the medicinal product and the onset of an AE	From the start of Lipacreon treatment to the end of the observation period or discontinuation. Approximately 7 years in the study completers (From date of dosage start, up to 7 years).
Secondary	Nutritional Endpoints - BMI	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •BMI (height [only prior to the start of Lipacreon treatment] and weight)	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Nutritional Endpoints - Serum Total Protein	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Serum total protein	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Nutrition Endpoints - Albumin	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Albumin	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Nutrition Endpoints - Total Cholesterol	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Total cholesterol	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Nutrition Endpoints - Triglycerides	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Triglycerides	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Nutrition Endpoints - Haemoglobin	The following nutritional endpoints were measured prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Haemoglobin	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Steatorrhoea	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Steatorrhoea (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Frequency of Bowel Movements	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Frequency of bowel movements (times/day)	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Diarrhoea	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Diarrhoea (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Foul Stool Odour	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Foul stool odour (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Inappetence	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Inappetence (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Symptoms Related to Exocrine Pancreatic Insufficiency - Abdominal Distension	The following symptoms were assessed as those related to exocrine pancreatic insufficiency prior to the start of Lipacreon treatment, at 4, 8, and 24 weeks after the start of treatment, at the completion of the 52-week observation period, at 1-year intervals during the follow-up period, and at the completion of follow-up in March 2018.; •Abdominal distension (Yes/No)	Baseline, 4 weeks, 8 weeks, 24 weeks, 52 weeks, 2 years, 3 years, 4 years, 5 years, 6 years, and 7 years
Secondary	Degree of General Improvement	Degree of general improvement was assessed at 24 weeks after the start of Lipacreon treatment and at the completion of the 52-week observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable	At 24 weeks
Secondary	Degree of General Improvement	Degree of general improvement was assessed at 24 weeks after the start of Lipacreon treatment and at the completion of the 52-week observation period, using the following 4 grades: Improved, unchanged, exacerbated, unassessable	At 52 weeks