PancreatitisPhase 2NCT02025049
DP-b99 in the Treatment of Acute High-risk Pancreatitis
A Phase 2 study testing DP-b99 in people with Pancreatitis, run by D-Pharm Ltd. at 1 site in Czechia.
Trial summary
Inflammation of the pancreas often leads to severe damage not only to the pancreas but also to other organs in the abdomen as well as to complications in organs further away like the lung and the kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis
- What is being tested?
- DP-b99
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- Dec 2013to May 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subject.
- Age 18 years or higher.
- First in a lifetime episode of acute pancreatitis.
- Diagnosis of acute pancreatitis based on 2 of the following 3 criteria: (1) typical upper abdominal pain; (2) elevation of serum amylase and/or lipase at least 3 times the upper limit of normal; (3) contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis
- History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening).
- BISAP score of 3 or higher
- Study treatment initiation is possible within 48 h of symptom onset
- Ability to provide informed consent
Who cannot join
- Drug-induced, viral, hereditary or post-ERCP pancreatitis.
- Recurrent episode of pancreatitis.
- CT evidence of pancreatic necrosis at study entry.
- Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter less than 6 mm (above 80 years, less than 8 mm) with gallbladder in situ.
- Severe chronic renal failure (Modification of Diet in Renal Disease formula 30 mL/min or dependency on renal dialysis).
- High likelihood for an invasive intra-biliary tract intervention (e.g. ERCP) in the coming week.
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- Class II or greater New York Heart Association heart failure.
- Oxygen-dependent chronic obstructive pulmonary disease (COPD).
- Cirrhosis of the liver.
- Severe anemia (hemoglobin less than 8 g/dL).
- Hematocrit below 35 % or above 45 % at study entry (fluids may be administered to correct the hematocrit before randomisation as long as study treatment starts within 48 hours of symptoms onset).
- Serum alanine aminotransferase above 250 IU/L at study entry.
- Clinical suspicion of ascending cholangitis at study entry.
- Active gastrointestinal bleeding.
- Current malignancy not in remission (other than basal cell carcinoma of skin).
- Altered mental status.
- Current breastfeeding or pregnancy.
- Female of childbearing potential (less than 2 years postmenopausal or not surgically sterilized) who is not willing to use adequate and effective birth control measures
- Known hypersensitivity to any component of the investigational product.
- Dependent relationship with the investigator or the sponsor.
- Participation in an investigational drug study during this clinical trial or within 30 days prior to start of this clinical trial
Trial locations and contacts
1 site in 1 country.
Czechia1 site
The University Hospital Brno, Gastroenterology Clinic
Brno, 62500
About this study
Official title: Pilot Trial of Intravenous DP-b99 in the Treatment of First-ever Episode of Non-obstructive Acute High-risk Pancreatitis
Inflammation of the pancreas often leads to severe damage not only to the pancreas but also to other organs in the abdomen as well as to complications in organs further away like the lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe inflammation of the pancreas, can mitigate the development of processes that can lead to serious complications of this disease.
Read the detailed description
The study will be a randomised, double blind, placebo-controlled, multi-centre, multi-national, parallel-arm study comparing a placebo group to a DP-b99 group treated intravenously with 1.0 mg/kg twice daily for 2 consecutive days.
The study will enrol 30 patients at high risk of developing severe pancreatitis, as assessed by the Bedside Index for Severity in Acute Pancreatitis (BISAP) score of 3 or more at study entry.
The primary study endpoint is the effect of DP-b99 on systemic inflammation in acute pancreatitis as reflected by C-reactive protein (CRP) plasma levels. The secondary endpoints are the safety of DP-b99 in this population of patients (through routine safety laboratory tests, physical examination and vital signs monitoring, ECG and adverse event reporting), DP-b99's effects on other plasma inflammatory markers (interleukin-6, matrix metalloproteinase 9, tumor necrosis factor alpha) as well as its effects on the clinical course of pancreatitis (based on changes in the Systemic Inflammatory Response Syndrome (SIRS) and Acute Physiology And Chronic Health Evaluation II (APACHE II) scores, and on contrast material-enhanced abdominal Computerised Tomography (CT), versus placebo.
Clinical trial material administration will begin within 48 hours of acute pancreatitis symptoms onset. Subjects will be randomised at a ratio of 1:1 to receive either DP b99 or placebo. The serum levels of DP-b99 at the end of each 2-hour infusion will also be monitored.
The study duration per individual subject will be 14 days, consisting of a screening evaluation followed by a 48-hour double blind treatment period, which will be part of an in-hospital observation period of at least 6 days, and a follow-up final visit on Day 14.
- Conditions
- Pancreatitis
- Being tested
- DP-b99, Placebo
- Keywords
- pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DP-b99Drug
Also called Chemical name: 1,2-Bis(2-aminophenoxy)ethane- N,N,N'N'-tetraacetic acid, N,N'-di(octyloxyethyl ester), N,N'-disodium salt, CAS Number: 222315-66-4
DP-b99 is a lipophilic analog of the divalent metal ion chelator O,O'-Bis(2-aminophenyl) ethyleneglycol-N,N,N',N'-tetraacetic acid (BAPTA)
PlaceboDrug
mannitol-based DP-b99 look-alike
| Study group | Role | What they receive |
|---|---|---|
| DP-b99 | Experimental | Intravenous DP-b99, 1.0 mg/kg twice daily for 2 consecutive days Receives: Drug: DP-b99 |
| Placebo | Placebo comparator | Intravenous placebo (mannitol based, DP-b99 look-alike) twice daily for 2 consecutive days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-reactive protein serum concentration
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionMay 2015
- Study completionMay 2015
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- D-Pharm Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gilad Rosenberg, MD, Study director, D-Pharm Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02025049
- Sponsor's protocol ID
- Ptcl-01501
- Status last verified
- Dec 2013
- First submitted
- 25 Dec 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Intravenous DP-b99 in the Treatment of First-ever Episode of Non-obstructive Acute High-risk Pancreatitis
- ClinicalTrials.gov ID
- NCT02025049
- Acronym / sponsor ID
- Ptcl-01501
- Conditions
- Pancreatitis
- Keywords
- pancreatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- D-Pharm Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 31 Dec 2013 (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.
Inflammation of the pancreas often leads to severe damage not only to the pancreas but also to other organs in the abdomen as well as to complications in organs further away like the lung and the kidney. This trial will examine if DP-b99, given to patients with non-severe inflammation of the pancreas, can mitigate the development of processes that can lead to serious complications of this disease.
Detailed description
The study will be a randomised, double blind, placebo-controlled, multi-centre, multi-national, parallel-arm study comparing a placebo group to a DP-b99 group treated intravenously with 1.0 mg/kg twice daily for 2 consecutive days.
The study will enrol 30 patients at high risk of developing severe pancreatitis, as assessed by the Bedside Index for Severity in Acute Pancreatitis (BISAP) score of 3 or more at study entry.
The primary study endpoint is the effect of DP-b99 on systemic inflammation in acute pancreatitis as reflected by C-reactive protein (CRP) plasma levels. The secondary endpoints are the safety of DP-b99 in this population of patients (through routine safety laboratory tests, physical examination and vital signs monitoring, ECG and adverse event reporting), DP-b99's effects on other plasma inflammatory markers (interleukin-6, matrix metalloproteinase 9, tumor necrosis factor alpha) as well as its effects on the clinical course of pancreatitis (based on changes in the Systemic Inflammatory Response Syndrome (SIRS) and Acute Physiology And Chronic Health Evaluation II (APACHE II) scores, and on contrast material-enhanced abdominal Computerised Tomography (CT), versus placebo.
Clinical trial material administration will begin within 48 hours of acute pancreatitis symptoms onset. Subjects will be randomised at a ratio of 1:1 to receive either DP b99 or placebo. The serum levels of DP-b99 at the end of each 2-hour infusion will also be monitored.
The study duration per individual subject will be 14 days, consisting of a screening evaluation followed by a 48-hour double blind treatment period, which will be part of an in-hospital observation period of at least 6 days, and a follow-up final visit on Day 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DP-b99 | Experimental | Drug: DP-b99Intravenous DP-b99, 1.0 mg/kg twice daily for 2 consecutive days |
| Placebo | Placebo comparator | Drug: PlaceboIntravenous placebo (mannitol based, DP-b99 look-alike) twice daily for 2 consecutive days |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subject.
- Age 18 years or higher.
- First in a lifetime episode of acute pancreatitis.
- Diagnosis of acute pancreatitis based on 2 of the following 3 criteria: (1) typical upper abdominal pain; (2) elevation of serum amylase and/or lipase at least 3 times the upper limit of normal; (3) contrast-material enhanced CT scan or abdominal sonogram demonstrating changes of acute pancreatitis
- History supporting alcoholic, hypertriglyceridemic or biliary etiology of the current pancreatitis episode (for biliary pancreatitis, a sonogram must exclude a stone obstruction at the time of study screening).
Key exclusion criteria (21 listed)
- Drug-induced, viral, hereditary or post-ERCP pancreatitis.
- Recurrent episode of pancreatitis.
- CT evidence of pancreatic necrosis at study entry.
- Imaging evidence of physical obstruction of the common bile duct at study entry; e.g. for abdominal sonogram, stone(s) in the common bile duct or common bile duct having diameter less than 6 mm (above 80 years, less than 8 mm) with gallbladder in situ.
- Severe chronic renal failure (Modification of Diet in Renal Disease formula 30 mL/min or dependency on renal dialysis).
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 |
|---|---|---|
| DP-b99Also: Chemical name: 1,2-Bis(2-aminophenoxy)ethane- N,N,N'N'-tetraacetic acid, N,N'-di(octyloxyethyl ester), N,N'-disodium salt, CAS Number: 222315-66-4DP-b99 is a lipophilic analog of the divalent metal ion chelator O,O'-Bis(2-aminophenyl) ethyleneglycol-N,N,N',N'-tetraacetic acid (BAPTA) | Drug | DP-b99 |
| Placebomannitol-based DP-b99 look-alike | Drug | Placebo |
Primary outcome
C-reactive protein serum concentration
Time frame: 6 days
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2015.
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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.
Gilad Rosenberg, MD study director
D-Pharm Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DP-b99 in people with Pancreatitis, run by D-Pharm Ltd. at 1 site in Czechia.
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 8 inclusion and 21 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: stopped early, as of the sponsor's last update on 23 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Slow recruitment). Results are not available in the source record.
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?
C-reactive protein serum concentration (time frame: 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jun 2015.