Cystic FibrosisPhase 3DIGESTNCT00449878
Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
A Phase 3 study testing Liprotamase in people with Cystic Fibrosis and Exocrine Pancreatic Insufficiency, run by Anthera Pharmaceuticals at 29 sites in United States.
Trial summary
This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI). Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- What is being tested?
- Liprotamase
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 29 sitesUnited States
- Study dates
- May 2007to Jun 2008
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Females of childbearing potential must be willing to use birth control
- Diagnosis of CF based upon the following criteria:
- two clinical features consistent with CF; and
- either genotype with two identifiable mutations consistent with CF, OR
- sweat chloride >60 mEq/L by quantitative pilocarpine iontophoresis
- Clinically stable with no evidence of acute upper or lower respiratory tract infection
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- PI determined by fecal elastase <100 µg/g stool measured at screening
- Able to take pancreatic enzyme supplementation in the form of capsules
- Able to perform the testing (e.g., stool collections) and inpatient stays required for this study, as judged by the Investigator
- Baseline coefficient of fat absorption (CFA) less than or equal to 80%
Who cannot join
- CFA >80% at Baseline
- Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
- History of fibrosing colonopathy
- History of liver transplant, lung transplant or significant surgical resection of the bowel
- Any acute or chronic diarrheal illness unrelated to PI
- Unable to discontinue enteral tube feedings during the study
Show all 15Show fewer
- Known hypersensitivity to food additives
- Inability to consume the diet required by the study, in the judgment of the Investigator
- Participation in an investigational study of a drug, biologic, or device not currently approved for marketing within 30 days prior to screening
- Abnormal liver function (except for patients with Gilbert Syndrome)
- Signs and/or symptoms of liver cirrhosis, portal hypertension or documented liver disease unrelated to CF
- Distal intestinal obstruction syndrome (DIOS) in the last six months prior to screening
- Unable to discontinue the use of pancreatic enzymes
- 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
- Patient is unlikely to complete the study, as determined by the Investigator
Trial locations and contacts
29 sites in 1 country.
29 sites in 1 country
United States29 sites
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Ann Arbor, Michigan, 26506
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Atlanta, Georgia, 30322
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buffalo, New York, 14215
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cincinnati, Ohio, 45267
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Cleveland, Ohio, 44106
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Dayton, Ohio, 45404
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Denver, Colorado, 80218
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Detroit, Michigan, 48224
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Durham, North Carolina, 27710
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Glenview, Illinois, 60025
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Grand Rapids, Michigan, 49503
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Hanover, New Hampshire, 03756
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Indianapolis, Indiana, 46202
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Iowa City, Iowa, 52242
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jackson, Mississippi, 39216
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Jacksonville, Florida, 32247
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Kalamazoo, Michigan, 49007
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Los Angeles, California, 90027
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Madison, Wisconsin, 53792
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Memphis, Tennessee, 38105
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Miami, Florida, 33136
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Milwaukee, Wisconsin, 53226
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Minneapolis, Minnesota, 55455
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Morgantown, West Virginia, 26506
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Pittsburgh, Pennsylvania, 15213
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Portland, Oregon, 97201
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Salt Lake City, Utah, 84132
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sioux Falls, South Dakota, 57117
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Stanford, California, 94305
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).
Read the detailed description
This trial is divided into four distinct periods:
- Baseline Period during which each patient is taken off pancreatic enzyme medications.
- An Open-Label Treatment Period during which all patients will receive ALTU-135 (liprotamase).
- Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo.
- Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 (liprotamase).
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Being tested
- Liprotamase, Placebo
- Keywords
- cystic fibrosis-related pancreatic insufficiency
- Medical subject headings
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiprotamaseDrug
Also called ALTU-135, LY3031642, TheraCLEC - Total
Administered orally
PlaceboDrug
Administered orally
| Study group | Role | What they receive |
|---|---|---|
| Liprotamase | Experimental | Liprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units).
Open Label Period: Liprotamase administered orally with each of three meals and two snacks daily for 21 days.
Double Blind Treatment Period: Administered orally with each of three meals and two snacks daily for 6 days.
Second Open Label Period: Administered orally with each of three meals and two snacks daily for 7 days. Receives: Drug: Liprotamase |
| Placebo | Placebo comparator | Double Blind Treatment Period: Placebo (microcrystalline cellulose) administered orally with each of three meals and two snacks daily for 6 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA)
Measured: Open label baseline, end of 6 day double blind treatment period
Secondary outcomes (4)
Change from open label baseline to end of 6 day double blind treatment period in Coefficient of nitrogen absorption (CNA)
Measured: Open label baseline, end of 6 day double blind treatment period
Change from open label baseline to end of 6 day double blind treatment period in number of stools
Measured: Open label baseline, end of 6 day double blind treatment period
Change from open label baseline to end of 6 day double blind treatment period in stool weight
Measured: Open label baseline, end of 6 day double blind treatment period
Change from open label baseline to end of 6 day double blind treatment period in maximum blood glucose
Measured: Open label baseline, end of 6 day double blind treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2007 (estimated)
- Study startMay 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anthera Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00449878
- Sponsor's protocol ID
- 14293
- Other IDs
- I5L-MC-TCAB, 726
- Acronym
- DIGEST
- Status last verified
- Oct 2014
- First submitted
- 19 Mar 2007
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
PubMed 32761612
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
- ClinicalTrials.gov ID
- NCT00449878
- Acronym / sponsor ID
- DIGEST / 14293
- Conditions
- Cystic Fibrosis, Exocrine Pancreatic Insufficiency
- Keywords
- cystic fibrosis-related pancreatic insufficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Anthera PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 21 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a clinical trial which will evaluate the efficacy of Liprotamase treatment in cystic fibrosis (CF) patients with exocrine pancreatic insufficiency (PI).
Detailed description
This trial is divided into four distinct periods:
- Baseline Period during which each patient is taken off pancreatic enzyme medications.
- An Open-Label Treatment Period during which all patients will receive ALTU-135 (liprotamase).
- Inpatient, Double Blind Treatment Period during which half of patients will be withdrawn from treatment and will receive Placebo.
- Second Open-Label Treatment Period during which all patients will resume treatment with ALTU-135 (liprotamase).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liprotamase | Experimental | Drug: LiprotamaseLiprotamase is a fixed combination of lipase (32,500 units), protease (25,000 units) and amylase (3,750 units). Open Label Period: Liprotamase administered orally with each of three meals and two snacks daily for 21 days. Double Blind Treatment Period: Administered orally with each of three meals and two snacks daily for 6 days. Second Open Label Period: Administered orally with each of three meals and two snacks daily for 7 days. |
| Placebo | Placebo comparator | Drug: PlaceboDouble Blind Treatment Period: Placebo (microcrystalline cellulose) administered orally with each of three meals and two snacks daily for 6 days. |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Females of childbearing potential must be willing to use birth control
- Diagnosis of CF based upon the following criteria:
- Clinically stable with no evidence of acute upper or lower respiratory tract infection
- PI determined by fecal elastase <100 µg/g stool measured at screening
- Able to take pancreatic enzyme supplementation in the form of capsules
Key exclusion criteria (15 listed)
- CFA >80% at Baseline
- Pregnancy, breastfeeding or of childbearing potential and not willing to use birth control during the study
- History of fibrosing colonopathy
- History of liver transplant, lung transplant or significant surgical resection of the bowel
- Any acute or chronic diarrheal illness unrelated to PI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LiprotamaseAlso: ALTU-135, LY3031642, TheraCLEC - TotalAdministered orally | Drug | Liprotamase |
| PlaceboAdministered orally | Drug | Placebo |
Primary outcome
Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA)
Time frame: Open label baseline, end of 6 day double blind treatment period
4 secondary outcomes
Change from open label baseline to end of 6 day double blind treatment period in Coefficient of nitrogen absorption (CNA)
Time frame: Open label baseline, end of 6 day double blind treatment period
Change from open label baseline to end of 6 day double blind treatment period in number of stools
Time frame: Open label baseline, end of 6 day double blind treatment period
Change from open label baseline to end of 6 day double blind treatment period in stool weight
Time frame: Open label baseline, end of 6 day double blind treatment period
Change from open label baseline to end of 6 day double blind treatment period in maximum blood glucose
Time frame: Open label baseline, end of 6 day double blind treatment period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Derived from this study: PubMed 32761612Somaraju URR, Solis-Moya A. Pancreatic enzyme replacement therapy for people with cystic fibrosis. Cochrane Database Syst Rev. 2020 Aug 5;8(8):CD008227. doi: 10.1002/14651858.CD008227.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
29 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liprotamase in people with Cystic Fibrosis and Exocrine Pancreatic Insufficiency, run by Anthera Pharmaceuticals at 29 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from open label baseline to end of 6 day double blind treatment period in Coefficient of Fat Absorption (CFA) (time frame: Open label baseline, end of 6 day double blind treatment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00449878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2014.