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Last Updated: June 6, 2020

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CLINICAL TRIALS PROFILE FOR POLYETHYLENE GLYCOL 3350

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505(b)(2) Clinical Trials for Polyethylene Glycol 3350

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00681265 Tear Film Break-up Time After Instillation of Artificial Tears Completed Eyeon Therapeutics, Inc. N/A 2008-06-01 This study is an exploratory trial evaluating the tear film break-up time after a single eye drop instillation of over-the-counter artificial tears. The primary hypothesis is that tear film break up time will be greater for test than control eye.
OTC NCT01044212 Bowel Function After Minimally Invasive Urogynecologic Surgery Completed University of Rochester N/A 2009-11-01 The purpose of this study is to assess the effect of a standardized postoperative bowel regimen of over-the-counter medications in subjects undergoing minimally invasive urogynecologic surgery.
New Formulation NCT01325896 Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON) Unknown status Haematology Service, Phase 2 2002-09-01 - Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease. - High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant. - To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis. - Intron A s.c. need administration of 3 days per week and is not well tolerated - Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM. - The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
New Formulation NCT01325896 Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT) Using Polyethylene Glycol alpha2B Interpheron (PEG-INTRON) Unknown status Fundación de Investigación Biomédica - Hospital Universitario de La Princesa Phase 2 2002-09-01 - Multiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease. - High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant. - To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis. - Intron A s.c. need administration of 3 days per week and is not well tolerated - Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM. - The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Polyethylene Glycol 3350

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001410 PEG-Glucocerebrosidase for the Treatment of Gaucher Disease Completed National Institute of Mental Health (NIMH) Phase 1 1993-10-01 Gaucher disease is a lysosomal storage disease resulting from glucocerebroside accumulation in macrophages due to a genetic deficiency of the enzyme glucocerebrosidase. It may occur in patients of all ages. The condition is marked by enlargement of the liver and spleen (hepatosplenomegaly), low blood and platelet counts, and bone abnormalities. The condition is passed from generation to generation on via autosomal recessive inheritance. There are actually three types of Gaucher disease. Type I is the most common form. It is a chronic non-neuronopathic form, meaning the disease does not affect the nervous system. The symptoms of type I can appear at any age. Type 2 Gaucher disease presents prenatally or in infancy and usually results in death for the patient. Type 2 is an acute neuronopathic form and can affect the brain stem. It is the most severe form of the disease. Type 3 Gaucher disease is also neuronopathic, however it is subacute in nature. This means the course of the illness lies somewhere between long-term (chronic) and short-term (acute). Currently there is not a cure for Gaucher disease. Treatment for the disease has traditionally been supportive. In some severely affected patients, bone-marrow transplants have corrected the enzyme deficiency, but it is considered a high-risk procedure and recovery can be very slow. Enzyme replacement therapy is another therapy option and has been approved by the Food and Drug Administration (FDA) for use in type 1 patients. PEG-glucocerbrosidase is a drug designed to clear out the accumulation of lipid (glucocerebroside) from the blood stream. The drug is actually an enzyme attached to large molecules called polyethylene glycol (PEG). The large molecules of PEG allow the enzyme to remain in the blood stream for long periods of time. By modifying glucocerebrosidase with PEG, it is believed that smaller doses will be required, meaning a reduction in cost for the patient and more convenient administration of the drug. The purpose of this study is to evaluate the effects and safety of enzyme replacement therapy using PEG- glucocerebrosidase for the treatment of Gaucher disease.
NCT00004695 Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients With Common Variable Immunodeficiency Completed Icahn School of Medicine at Mount Sinai N/A 1997-09-01 OBJECTIVES: I. Determine whether polyethylene-glycol-conjugated interleukin 2 (PEG-IL-2) can reduce the number of infections in patients with common variable immunodeficiency. II. Determine whether this therapy can improve lung functions in these patients with pulmonary impairment.
NCT00018031 Peginterferon Alpha-2b And Ribavirin to Treat Hepatitis C in HIV-Infected Patients Completed National Institute of Allergy and Infectious Diseases (NIAID) Phase 2 2001-06-01 This study will evaluate the safety and effectiveness of combination therapy with peginterferon alfa-2b and ribavirin for treating hepatitis C virus (HCV) infection in HIV-infected patients. In studies of patients with hepatitis C alone, interferon alfa-2b plus ribavirin treatment eradicated the HCV in almost half the patients. Peginterferon alfa-2b is a compound that results from attaching a polyethylene glycol molecule to interferon alfa-2b. This compound stays in the blood longer than unmodified interferon alfa-2b, causing a higher blood concentration and thus maintaining activity against the hepatitis C virus. HIV-infected patients 21 years of age and older with chronic hepatitis C infection and a viral load greater than 2000 copies/mL may be eligible for this 2 1/2-year study. Candidates will be screened with blood and urine tests and possibly a liver biopsy, if a recent one is not available. The liver biopsy is done to determine the severity of liver disease. For this test, patients are admitted to the NIH Clinical Center for 1 to 2 days. A sedative is injected into an arm vein, the skin in the area over the biopsy site is numbed with a local anesthetic, and a needle is inserted rapidly into and out of the liver to obtain a small tissue sample. The patient remains in the hospital overnight for monitoring. A chest X-ray, electrocardiogram (EKG) and liver ultrasound are also done. Within 4 weeks of the screening tests, candidates who appear eligible for the study will have a physical examination, medical history and repeat blood tests. Women who can become pregnant will have serial pregnancy tests throughout the study. Patients who meet the study criteria and decide to participate will begin treatment with weekly injections under the skin of peginterferon alfa-2b and take ribavirin pills twice a day by mouth. In addition, patients will continue to take all other medications prescribed by their doctor. Clinic visits will be scheduled as follows: - Days 1, 3, 5, 7, 10 and 21 - Blood will be drawn for safety tests and to measure blood levels of HIV and HCV. - Weeks 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 52, 56 and 64 - Blood and urine tests will be done to determine the side effects of treatment and its effect on the HCV infection. - Week 48 or end of treatment - Treatment will stop after 48 weeks. At this time, or earlier for those who do not complete the 48 weeks, patients will return to the clinic for a routine test.
NCT00029900 ADI-PEG in Patients With Metastatic Melanoma Completed FDA Office of Orphan Products Development Phase 1 2001-09-01 This is a study to determine the safety and toxicity of increasing doses of arginine deiminase combined to polyethylene glycol (ADI-PEG) in patients with nonresectable metastatic melanoma.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Polyethylene Glycol 3350

Condition Name

Condition Name for Polyethylene Glycol 3350
Intervention Trials
Constipation 23
Anemia 18
Colonoscopy 17
Bowel Preparation 13
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Condition MeSH

Condition MeSH for Polyethylene Glycol 3350
Intervention Trials
Constipation 30
Anemia 19
Hepatitis A 12
Hepatitis 12
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Clinical Trial Locations for Polyethylene Glycol 3350

Trials by Country

Trials by Country for Polyethylene Glycol 3350
Location Trials
United States 182
China 49
Italy 28
Spain 23
Korea, Republic of 17
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Trials by US State

Trials by US State for Polyethylene Glycol 3350
Location Trials
Texas 14
New York 12
Pennsylvania 11
California 10
Maryland 10
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Clinical Trial Progress for Polyethylene Glycol 3350

Clinical Trial Phase

Clinical Trial Phase for Polyethylene Glycol 3350
Clinical Trial Phase Trials
Phase 4 80
Phase 3 45
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Polyethylene Glycol 3350
Clinical Trial Phase Trials
Completed 127
Recruiting 38
Not yet recruiting 36
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Clinical Trial Sponsors for Polyethylene Glycol 3350

Sponsor Name

Sponsor Name for Polyethylene Glycol 3350
Sponsor Trials
Hoffmann-La Roche 27
Jiangsu Hansoh Pharmaceutical Co., Ltd. 6
Boehringer Ingelheim 5
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Sponsor Type

Sponsor Type for Polyethylene Glycol 3350
Sponsor Trials
Other 244
Industry 108
NIH 11
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