Safety and Efficacy Study of VP20621 for Prevention of Recurrent Clostridium Difficile Infection

Shire

Status and phase: Completed; Phase 2

Conditions: Clostridium Difficile Infection

Treatments: Biological: VP20621; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01259726

VP20621-200

2010-020484-20 (EudraCT Number)

Details and patient eligibility

About

The objectives of this study are: (1) to evaluate the safety and tolerability of VP 20621 dosed orally for up to 14 days in adults previously treated for CDI; (2) to characterize the frequency and duration of stool colonization with the VP 20621 strain of C. difficile; (3) to evaluate the efficacy of VP 20621 for prevention of recurrence of CDI; and (4)to select a dose regimen of VP 20621 to be used in future studies.

Enrollment: 173 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult subjects, 18 years of age and over, who understand the risks and benefits of participation and have provided written informed consent for the study.
2. Subjects who are experiencing a first event or first recurrence of clostridium difficile (CDI) within the last 28 days and have been successfully treated with an antibiotic for CDI.
3. Subjects who are medically stable.
4. Subjects who are willing and able to comply with the study procedures and visit schedules outlined.
5. If female be post-menopausal, surgically sterile or agree to follow an acceptable method of birth control.

Exclusion criteria

1. Subjects who have had more than 2 episodes of CDI within the last 6 months.
2. Subjects who have been diagnosed with Inflammatory Bowel Disease,active Irritable Bowel Syndrome, celiac disease, active gastroparesis, toxic megacolon.
3. GI surgery within 6 weeks before the day of randomization
4. Have known immunodeficiency disorder, such as HIV Infection
5. Pregnant or breast feeding females.
6. Concurrent acute life-threatening diseases.
7. Inability to tolerate oral liquids.
8. Have an absolute neutrophil count < 1000/mm3 at screening

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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173 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Other: Placebo

VP20621 Low Dose and Placebo

Experimental group

Treatment:

Other: Placebo

Biological: VP20621

Biological: VP20621

Biological: VP20621

VP20621 High Dose and Placebo

Experimental group

Treatment:

Other: Placebo

Biological: VP20621

Biological: VP20621

Biological: VP20621

VP20621 High Dose

Experimental group

Treatment:

Biological: VP20621

Biological: VP20621

Biological: VP20621