Trial Outcomes & Findings for Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection (NCT NCT00575185)

NCT ID: NCT00575185

Last Updated: 2017-03-22

Results Overview

All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 23 participants
• Primary outcome timeframe: 21 days
• Results posted on: 2017-03-22

Participant Flow

University of Minnesota students that contracted Mono and wsere seen at the student health center

Participant milestones

Measure	Valomaciclovir Valomaciclovir 2 grams orally twice daily for 21 days Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.	Placebo placebo 2 tablets twice daily for 21 days placebo : Placebo tablets orally twice daily for 21 days.
Overall Study STARTED	12	11
Overall Study COMPLETED	12	11
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Activity of Valomaciclovir in Infectious Mononucleosis Due to Primary Epstein-Barr Virus Infection

Baseline characteristics by cohort

Measure	Valomaciclovir n=12 Participants Valomaciclovir 2 grams orally twice daily for 21 days Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.	Placebo n=11 Participants placebo 2 tablets twice daily for 21 days placebo : Placebo tablets orally twice daily for 21 days.	Total n=23 Participants Total of all reporting groups
Age, Customized <=18 years	0 particpants n=5 Participants	0 particpants n=7 Participants	0 particpants n=5 Participants
Age, Customized Between 18 and 65 years	12 particpants n=5 Participants	11 particpants n=7 Participants	23 particpants n=5 Participants
Age, Customized >=65 years	0 particpants n=5 Participants	0 particpants n=7 Participants	0 particpants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	11 participants n=7 Participants	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 21 days

All subjects had confirmed cases of EB and will be assessed for Improvement of clinical symptoms (ie: tiredness, nausea etc)and reduction in viral burden from baseline

Outcome measures

Measure	Valomaciclovir n=12 Participants Valomaciclovir 2 grams orally twice daily for 21 days Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.	Placebo n=11 Participants placebo 2 tablets twice daily for 21 days placebo : Placebo tablets orally twice daily for 21 days.
Number of Participants With Improvement in Clinical Symptoms and Reductions in Viral Burden From Baseline	12 participants	11 participants

SECONDARY outcome

Timeframe: 15 days

Assessing adverse events in participants to see if this drug causes more or less side effects

Outcome measures

Measure	Valomaciclovir n=12 Participants Valomaciclovir 2 grams orally twice daily for 21 days Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.	Placebo n=11 Participants placebo 2 tablets twice daily for 21 days placebo : Placebo tablets orally twice daily for 21 days.
Number of Participants Who Experienced Adverse Events During the Study Safety and Tolerability	12 participants	11 participants

Adverse Events

Valomaciclovir

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Measure	Valomaciclovir n=12 participants at risk Valomaciclovir 2 grams orally twice daily for 21 days Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.	Placebo n=11 participants at risk placebo 2 tablets twice daily for 21 days placebo : Placebo tablets orally twice daily for 21 days.
Endocrine disorders Pancreatitis	8.3% 1/12 • Number of events 1	0.00% 0/11

Other adverse events

Measure	Valomaciclovir n=12 participants at risk Valomaciclovir 2 grams orally twice daily for 21 days Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days.	Placebo n=11 participants at risk placebo 2 tablets twice daily for 21 days placebo : Placebo tablets orally twice daily for 21 days.
Gastrointestinal disorders Abdominal Pain	50.0% 6/12 • Number of events 6	45.5% 5/11 • Number of events 5
Nervous system disorders Headache	33.3% 4/12 • Number of events 4	45.5% 5/11 • Number of events 5
Gastrointestinal disorders Nausea	58.3% 7/12 • Number of events 7	9.1% 1/11 • Number of events 1
Gastrointestinal disorders Vomiting	25.0% 3/12 • Number of events 3	0.00% 0/11
Skin and subcutaneous tissue disorders Rash	16.7% 2/12 • Number of events 2	9.1% 1/11 • Number of events 1

Additional Information

Hank Balfour MD

University of Minnesota

Phone: (612) 626-5670

Email: balfo001@umn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place