Published Studies Related to Viokase (Lipase / Amylase / Protease)
Treatment of infants and toddlers with cystic fibrosis-related pancreatic insufficiency and fat malabsorption with pancrelipase MT. [2011.07]
BACKGROUND: Pancreatic enzyme replacement therapy (PERT) improves nutritional status and growth in patients with cystic fibrosis (CF) with pancreatic insufficiency (PI). The current recommendation for infants and young children, who are not able to swallow the whole capsule, is to open the capsule and mix the beads in a spoon with some applesauce; however, the efficacy and safety data of this approach are currently lacking. The aim of this study was to assess the efficacy, palatability (ease of swallowing), and safety of 4 dose levels of pancrelipase microtablets (Pancrease MT) in infants and young children with CF-related PI... CONCLUSION: Treatment with Pancrease MT at a dosage of 500 U lipase/kg/meal resulted in a CFA of approximately 89% in pediatric subjects ages 6 to 30 months with PI resulting from CF. Pancrease MT doses were well tolerated and mean palatability was scored as fair to good. Present results do not indicate that a dosage higher than 500 U (Ph. EUR) lipase/kg/meal increases the coefficient of fat absorption in a cohort of infants 6 to 30 months of age.
Pancrelipase delayed-release capsules (CREON) for exocrine pancreatic insufficiency due to chronic pancreatitis or pancreatic surgery: A double-blind randomized trial. [2010.10]
OBJECTIVES: Pancreatic-enzyme replacement therapy (PERT) is the standard of care to prevent maldigestion, malnutrition, and excessive weight loss in patients with exocrine pancreatic insufficiency (EPI) due to chronic pancreatitis (CP) or pancreatic surgery (PS). Our objective was to assess the efficacy and safety of a new formulation of pancrelipase (pancreatin) delayed-release 12,000-lipase unit capsules (CREON) in patients with EPI due to CP or PS... CONCLUSIONS: Pancrelipase delayed-release 12,000-lipase unit capsules were effective in treating fat and nitrogen maldigestion with a TEAE rate similar to that of placebo in patients with EPI due to CP or PS.
Pancrelipase Delayed-Release Capsules (CREON) for Exocrine Pancreatic Insufficiency due to Chronic Pancreatitis or Pancreatic Surgery: A Double-Blind Randomized Trial. [2010.05.25]
CONCLUSIONS:Pancrelipase delayed-release 12,000-lipase unit capsules were effective in treating fat and nitrogen maldigestion with a TEAE rate similar to that of placebo in patients with EPI due to CP or PS.Am J Gastroenterol advance online publication, 25 May 2010; doi:10.1038/ajg.2010.201.
Efficacy and tolerability of a new formulation of pancrelipase delayed-release capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled, two-period crossover, superiority study. [2010.01]
BACKGROUND: Pancreatic enzyme replacement therapy (PERT) is essential for maintaining adequate nutrition in children with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The US Food and Drug Administration regulations now require all PERT products to undergo clinical efficacy and safety studies before they can be considered for marketing approval. OBJECTIVE: This study was conducted to compare the efficacy of a new formulation of pancrelipase (pancreatin) delayed-release 12,000-lipase unit capsules with placebo in children with EPI due to CF... CONCLUSIONS: In this study in children with EPI due to CF, the new formulation of pancrelipase delayedrelease capsules was associated with improvements in CFA, CNA, stool properties, and EPI symptoms compared with placebo. Pancrelipase delayed-release capsules appeared to be well tolerated. ClinicalTrials.gov identifier: NCT00690820. (Clin Ther.
Efficacy and tolerability of a new formulation of pancrelipase delayed-release
capsules in children aged 7 to 11 years with exocrine pancreatic insufficiency
and cystic fibrosis: a multicenter, randomized, double-blind, placebo-controlled,
two-period crossover, superiority study. 
placebo in children with EPI due to CF... CONCLUSIONS: In this study in children with EPI due to CF, the new formulation of
Clinical Trials Related to Viokase (Lipase / Amylase / Protease)
Assessment of Insulin Production From Native Pancreas in Patients With Pancreas Transplants [Completed]
This study will examine whether insulin-producing cells in the pancreas (beta cells) can
recover in patients with type 1 diabetes who have had a pancreas transplant. In type 1
diabetes, the body's immune system destroys the beta cells. Patients are treated with
insulin shots or a pancreas transplant to control their blood sugar. Some experiments suggest
that the pancreas may have the capacity to recover some of its insulin-producing capacity,
but that ability is negated by factors such as the continuing immune attack and erratic blood
sugar levels in patients.
Patients who have had a pancreas transplant may be in a unique situation to allow their own
pancreas to regrow beta cells for two reasons: 1) the medicines they take to prevent
rejection of the transplanted pancreas weaken their immune system; and 2) they have
near-normal blood sugar levels because of their functioning transplanted pancreas. This study
will test this hypothesis by sampling blood from patients' hepatic vein, which drains the
liver and native pancreas and from their iliac vein, which drains the transplanted pancreas.
This will determine whether insulin is coming from the transplanted pancreas (iliac vein) or
the liver and native pancreas (hepatic vein).
Patients 18 years of age and older who have had stable pancreatic transplant function for
more than 5 years may be eligible for this study. Candidates are screened with a medical
history and physical examination.
Participants are admitted to the hospital for 2 days for a full medical examination, blood
tests and procedures to determine insulin production. The procedures will include the
placement of catheters in the neck and groin for blood sampling. Participants will be
closely monitored after the procedures and discharged home if there are no complications.
Viokase 16, Viokase16 Plus Nexium and Nexium Alone [Recruiting]
Our primary hypothesis is that the addition of Nexium to Viokase 16 will decrease the
chronic abdominal pain in patients with small duct chronic pancreatitis in a superior
fashion compared to Viokase 16 plus placebo or to Nexium alone. A secondary hypothesis would
be an increase in quality of life. Our objective is to elucidate the role of Nexium in the
control of pancreatic pain, quality of life, and narcotic usage alone or when added to
Viokase 16. Our endpoints are the reduction of abdominal pain, decreased pain medication
usage, decreased ER visits and decreased hospital admissions for abdominal pain.
A Study To Compare Sirolimus Versus Tacrolimus In De Novo Simultaneous Pancreas- Kidney Allograft Recipients Receiving An Induction Therapy With Antithymocyte Globulin Plus Mycophenolate Mofetil Plus Corticosteroids [Recruiting]
Experience with tacrolimus in pancreas transplantation has become a standard for
immunosuppression in almost all pancreas centers over the world. Several centers have shown
very good results in simultaneous pancreas-kidney (SPK) transplant recipients receiving
antithymocyte globulin induction and maintenance immunosuppression consisting of calcineurin
inhibitor and mycophenolate mofetil with or without corticosteroids.
The use of sirolimus in SPK transplant patients has for the moment only been studied, with
good results, in association with tacrolimus or cyclospsorine (CsA). In renal
transplantation, there is also evidence that sirolimus (Rapamune) is a potent
immunosuppressant that significantly reduces the incidence of acute rejection when given
with CsA, effective as base therapy in the post-induction period. Because of Rapamune's
effectiveness and different safety profile, it might be advantageous in terms of reduced
nephrotoxicity to avoid completely calcineurin inhibitors without increased incidence of
To explore this further, the following study is designed to assess the use of SRL versus
TAC, both treatment groups including rATG plus MMF and a 3-month course of steroids in de
novo simultaneous pancreas-kidney transplant recipients.
Pancreas Allotransplantation for Diabetic Nephropathy and Mild Chronic REnal fAilure Stage Study [Recruiting]
Current medical therapies are not able to prevent progression of established
macroproteinuira (i. e. diabetic nephropathy) to end-stage renal failure in type 1 (insulin
dependent) diabetic patients. In this setting, proteinuria is a major risk factor for
mortality. Pancreas transplantation, on the contrary, can revert diabetic nephropathy and
thereby prevent end-stage chronic renal failure, with theoretically lower risk of death as
compared to current medical therapies. The main objective of this study is to assess
superiority of isolated pancreas transplantation versus intensive exogenous insulin therapy
in type 1 diabetic patients with overt diabetic nephropathy and mildly reduced renal
function. The primary endpoint is a composite efficacy/failure end-point including: patient
mortality and renal function impairment during 5 years in patients with badly controlled
diabetes and nephropathy resisting to up-to-date nephroprotective therapies. Main secondary
objectives are safety and efficacy of both regimens, including proteinuria and renal
histology evaluation, metabolic control and quality of life, acute and chronic extrarenal
complications of diabetes, pancreas survival and all risks related to the transplant
procedure (anaesthesia, surgery and immunosuppression side-effects) and to the intensive
insulin therapy management.
GVAX Pancreas Vaccine With or Without CRS-207 for Advanced Pancreatic Cancer [Recruiting]
- The GVAX pancreas vaccine is made from pancreatic cancer cells. The cells are changed
in a laboratory to make a protein that helps to activate the immune system cells to
recognize and attack the cancer cells. The vaccine will be given as six injections
(shots) under the skin. This vaccine is experimental and it is not yet known if it will
be helpful to patients with pancreatic cancer.
- CRS-207 is a weakened form of the Listeria bacteria commonly found in the environment
(called wild-type ). Wild-type Listeria can sometimes cause food poisoning and other
infections. The bacteria in CRS-207 have been modified to help stimulate the immune
system without causing infection.
- To test the safety and effectiveness of the GVAX pancreas vaccine with low doses of
cyclophosphamide and CRS-207.
- Have histologically proven malignant adenocarcinoma of the pancreas
- Locally advanced disease may have non-evaluable disease
- Be at least 18 years of age
- Have an Eastern Cooperative Oncology Group performance status of 0-1
- Have an anticipated life expectancy of greater than 12 weeks
- No history or evidence of brain metastases
- No allergy to both penicillin and sulfa
- No artificial joint or implant ( dental, breast, and portacaths are allowed if no
history of infection or adverse events with implants)
- No history of HIV, hepatitis B or hepatitis C
- No history of active autoimmune disease or history of autoimmune disease requiring
steroids or immunosuppressive treatment.
- No unhealed surgical wounds
- At least 28 days post surgery, steroids or investigational products.
- Participants will be screened with a physical exam and medical history. They will also
have blood and urine tests, and imaging studies.
- Participants will be in one of two treatment groups. One group will have two doses of
GVAX pancreas vaccine and chemotherapy. This will be followed by four doses of CRS-207.
The other group will have six doses of GVAX pancreas vaccine with chemotherapy and no
- Everyone in the study will have the GVAX pancreas vaccine and chemotherapy at weeks 1
and 4 of the study. Treatment will be monitored with frequent regular tests and imaging
- The first treatment group will receive CRS-207 infusions at Week 7. Infusions will be
given in weeks 7, 10, 13, and 16. Participants may need to take antibiotics at certain
points during CRS-207 treatment to help clear the drug from the system.
- The second treatment group will have the vaccine and chemotherapy only at weeks 7, 10,
13, and 16.
- Participants will have a final followup exam at Week 20, with a physical exam, blood
tests, and imaging studies.