Safety, Tolerability and Efficacy of 12-weeks of Sovaprevir, ACH-3102 and Ribavirin in Treatment-naive GT-1 HCV Subjects

• Sponsor: Alexion Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01849562
• Collaborator: (none)
• Enrollment: 30
• Locations: 8
• Arms: 3
• Duration (Months): 12
• Patients Per Site: 3.8
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability and efficacy of 12 weeks of treatment with sovaprevir, ACH-0143102 and ribavirin in GT1, treatment-naive, HCV subjects.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic	Drug: Sovaprevir; Drug: ACH-3102; Drug: RBV; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2a Trial to Evaluate the Safety, Tolerability and Efficacy of 12 Weeks of Sovaprevir, ACH-0143102 and Ribavirin in Treatment-Naive Subjects With Chronic Hepatitis C Genotype-1 Viral Infection
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Nov 1, 2013
• Actual Study Completion Date: Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks	Drug: Sovaprevir; NS3/4A protease inhibitor; Other Names: ACH-0141625 ; Drug: ACH-3102; NS5A inhibitor; Drug: RBV; Other Names: Ribavirin
Active Comparator: Sovaprevir 400 mg, ACH-3102 150/50mg,RBV1000-1200mg Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks	Drug: Sovaprevir; NS3/4A protease inhibitor; Other Names: ACH-0141625 ; Drug: ACH-3102; NS5A inhibitor; Drug: RBV; Other Names: Ribavirin
Placebo Comparator: Placebo Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment. [Four weeks after the completion of treatment]

   Incidence of SVR4 after the completion of dosing, reported as HCV RNA less than the lower limit of quantification (<LLOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo.

2. Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection. [12 weeks]

   To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1, the following criteria will be used: the number of subjects with discontinuations due to AEs, treatment emergent G3/G4 AEs, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Males and Females between ages 18 and 65

• Chronic HCV infection

• HCV genotype 1

• HCV RNA > 10,000 IU/mL at screening.

• Female patients must be willing to use two effective methods of contraception, one of which must be barrier method, during dosing period and six months after last dose of ribavirin. Females of childbearing potential must have a negative pregnancy test at screening and baseline.

• Male patients must be willing to use an effective barrier method of contraception throughout the dosing period and for six months.

• Signed and dated written informed consent form.

• Willing to participate in all study activities and all study requirements (including effective contraception) during study period.

• Treatment naïve subjects defined as subjects who have never received pegylated interferon, RBV, or a direct-acting anti-viral agent for the treatment of chronic HCV infection.

• A liver biopsy within the last 3 years without evidence of cirrhosis.

Exclusion Criteria:

• Body Mass Index (BMI) > 36.0

• Pregnant or nursing (lactating) females, confirmed by a positive human chorionic gonadotropin (HCG) laboratory test or females contemplating pregnancy

• Participation in any interventional clinical trial within 35 days prior to first study medication dose administration on Day 1

• Known HIV-1 or HIV-2 infection/serology and/or positive Hepatitis B Surface Antigen (HBsAg)

• Use of dietary supplements, grapefruit juice, herbal supplements, CYP2C8 substrates, CYP3A4 inducers and inhibitors, PGP inducers and substrates, OATP inhibitors and substrates, and potent inducers of other CYP enzymes within 14 days prior to dosing through 7 days following completion of study meds.

• Clinically significant laboratory abnormality at screening (specified in protocol)

• Other forms of liver disease

• History of severe or uncontrolled psychiatric disease

• History of malignancy of any organ system, treated or untreated within the past 5 years

• History of major organ transplantation

• Use of bone marrow colony stimulating factor agents within 3 months prior to baseline.

• History of seizure disorder requiring ongoing medical therapy

• History of known coagulopathy including hemophilia

• History of hemoglobinopathy, including sickle cell anemia and thalassemia.

• History of immunologically mediated disease (specified in protocol)

• History of clinical evidence of significant chronic cardiac disease ( specified in protocol)

• ECG with any clinically significant abnormality.

• Structural or functional cardiac abnormalities (specified in protocol)

• History of COPD, emphysema, or other chronic lung disease.

• Subjects currently abusing amphetamines, cocaine or opiates, or with ongoing alcohol abuse in the judgement of the investigator

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Franco Felizarta	Bakersfield	California	United States	93301
2	eStudy Site	La Mesa	California	United States	91942
3	Gastrointestinal Specialists of Georgia	Marietta	Georgia	United States	30060
4	Nashville Gastrointestinal Specialists	Nashville	Tennessee	United States	78215
5	Liver Associates of Texas PA	Houston	Texas	United States	77030
6	American Research Corporation	San Antonio	Texas	United States	78215
7	Medical Associates of Central Virginia	Lynchburg	Virginia	United States	24501
8	Toronto Liver Centre	Toronto	Ontario	Canada	M6H3M1

Sponsors and Collaborators

• Alexion Pharmaceuticals

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexion Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01849562
• Other Study ID Numbers: ACH102-007
• First Posted: May 8, 2013
• Last Update Posted: Sep 17, 2015
• Last Verified: Sep 1, 2015

• Keywords provided by Alexion Pharmaceuticals: Hepatitis C, Chronic; Genotype 1; Hepatitis C; Liver Diseases; Hepatitis, viral, human; ribavirin; antiviral agents; anti-infective agents; protease inhibitors; NS5a inhibitors
• Additional relevant MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Ribavirin; Odalasvir

Study Results

Participant Flow

Recruitment Details	Participants were recruited from 7 sites in the US and 1 site in Canada between May 7, 2013 and April 4, 2014.
Pre-assignment Detail	Participants were screened within 4 weeks (-28 to -1) before administration of study drug. Subjects who meet all eligibility criteria were instructed to arrive at the study center on baseline day.

Arm/Group Title	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg	Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg	Placebo
Arm/Group Description	Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks Placebo
Period Title: Overall Study
STARTED	10	10	10
COMPLETED	8	10	10
NOT COMPLETED	2	0	0

Baseline Characteristics

Arm/Group Title	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg	Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg	Placebo	Total
Arm/Group Description	Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks Placebo	Total of all reporting groups
Overall Participants	10	10	10	30
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	9 90%	10 100%	10 100%	29 96.7%
>=65 years	1 10%	0 0%	0 0%	1 3.3%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	50.5 (11.36)	50.7 (8.51)	53.8 (8.58)	51.7 (9.4)
Sex: Female, Male (Count of Participants)
Female	4 40%	4 40%	4 40%	12 40%
Male	6 60%	6 60%	6 60%	18 60%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 20%	1 10%	1 10%	4 13.3%
Not Hispanic or Latino	8 80%	9 90%	9 90%	26 86.7%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 10%	0 0%	1 3.3%
Asian	0 0%	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	2 20%	2 20%	3 30%	7 23.3%
White	8 80%	7 70%	7 70%	22 73.3%
More than one race	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%
Weight (Kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg]	78.1 (15.02)	81.5 (9.88)	81.5 (11.9)	80.2 (12.1)
Height (CM) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [CM]	170.1 (11.14)	169.7 (9.76)	175.6 (7.53)	171.8 (9.66)

Outcome Measures

1. Primary Outcome

Title	Incidence of Sustained Virologic Response 4 Weeks (SVR4) After the Completion of Treatment.
Description	Incidence of SVR4 after the completion of dosing, reported as HCV RNA less than the lower limit of quantification (<LLOQ), in subjects who received active treatment (sovaprevir and ACH-0143102 in combination with ribavirin) as compared to those who received placebo.
Time Frame	Four weeks after the completion of treatment

Outcome Measure Data

Analysis Population Description

The analysis population for SVR4 was the full analysis (FA) set, defined as all randomized subjects who received at least one dose of study drug and had at least one baseline/post HCV RNA assessment. For this study, the FA set and the safety population were the same.

Arm/Group Title	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg	Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg	Placebo
Arm/Group Description	Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks Placebo
Measure Participants	10	10	10
Number [Percentage of Subjects with SVR4]	50	70	0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg, Placebo
	Comments	Differences in proportions between Group 1 (sovaprevir 200 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	50
	Confidence Interval	(2-Sided) 95%; 1.8 to 82.7
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg, Placebo
	Comments	Differences in proportions between Group 2 (sovaprevir 400 mg plus ACH-3102 150/50 mg plus RBV) and overall placebo (placebo from Group 1 and Group 2 combined) along with corresponding 95% confidence intervals for risk difference calculated using exact unconditional methods were obtained.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	70
	Confidence Interval	(2-Sided) 95%; 24.2 to 93.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Safety and Tolerability of 12 Weeks of Sovaprevir and 3102 in Combination With Ribavirin in Subjects With Chronic Hepatitis C Genotype 1 Viral Infection.
Description	To determine safety and tolerability of 12 weeks of sovaprevir/ACH-0143102/RBV in subjects with chronic hepatitis C genotype 1, the following criteria will be used: the number of subjects with discontinuations due to AEs, treatment emergent G3/G4 AEs, treatment emergent G3/G4 laboratory abnormalities, clinically significant ECGs.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

The analysis population for safety and tolerability was the safety population, defined as all randomized subjects who received at least one dose of study drug. For this study, the safety population and the FA set were the same.

Arm/Group Title	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg	Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-2000mg	Placebo
Arm/Group Description	Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin	Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks Placebo
Measure Participants	10	10	10
Discontinuations due to AEs	0 0%	0 0%	0 0%
Treatment Emergent G3/G4 AEs	0 0%	0 0%	0 0%
Treatment Emergent G3/G4 Abnormalities	3 30%	2 20%	0 0%
Clinically Significant ECGs	0 0%	0 0%	0 0%

Adverse Events

Time Frame	Adverse event data were collected from enrollment into the study through end of treatment plus 24 weeks of follow-up.
Adverse Event Reporting Description	Treatment-emergent adverse events are summarized.
Arm/Group Title	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg		Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg		Placebo
Arm/Group Description	Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin		Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks Sovaprevir: NS3/4A protease inhibitor ACH-3102: NS5A inhibitor Ribavirin		Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks Placebo
All Cause Mortality
	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg		Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg		Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		1/10 (10%)		0/10 (0%)
General disorders
Non-cardiac chest pain	0/10 (0%)	0	1/10 (10%)	1	0/10 (0%)	0
Other (Not Including Serious) Adverse Events
	Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg		Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/10 (100%)		10/10 (100%)		10/10 (100%)
Blood and lymphatic system disorders
Anaemia	2/10 (20%)		3/10 (30%)		0/10 (0%)
Lymphadenopathy	1/10 (10%)		0/10 (0%)		0/10 (0%)
Cardiac disorders
Palpitations	0/10 (0%)		1/10 (10%)		0/10 (0%)
Ear and labyrinth disorders
Tinnitus	1/10 (10%)		0/10 (0%)		0/10 (0%)
Eye disorders
Conjunctivitis	0/10 (0%)		1/10 (10%)		0/10 (0%)
Vision blurred	1/10 (10%)		0/10 (0%)		0/10 (0%)
Gastrointestinal disorders
Abdominal pain	1/10 (10%)		0/10 (0%)		0/10 (0%)
Abdominal pain upper	0/10 (0%)		1/10 (10%)		0/10 (0%)
Diarrhoea	1/10 (10%)		1/10 (10%)		2/10 (20%)
Dyspepsia	1/10 (10%)		0/10 (0%)		1/10 (10%)
Haemorrhoids	0/10 (0%)		1/10 (10%)		0/10 (0%)
Nausea	3/10 (30%)		3/10 (30%)		0/10 (0%)
Odynophagia	1/10 (10%)		0/10 (0%)		0/10 (0%)
Vomiting	2/10 (20%)		1/10 (10%)		0/10 (0%)
General disorders
Chest pain	1/10 (10%)		0/10 (0%)		0/10 (0%)
Fatigue	2/10 (20%)		3/10 (30%)		4/10 (40%)
Influenza like illness	1/10 (10%)		1/10 (10%)		0/10 (0%)
Irritability	2/10 (20%)		0/10 (0%)		0/10 (0%)
Non-cardiac chest pain	0/10 (0%)		1/10 (10%)		0/10 (0%)
Oedema peripheral	1/10 (10%)		0/10 (0%)		0/10 (0%)
Temperature intolerance	0/10 (0%)		0/10 (0%)		1/10 (10%)
Infections and infestations
Bronchitis	1/10 (10%)		0/10 (0%)		0/10 (0%)
Cellulitis	1/10 (10%)		0/10 (0%)		0/10 (0%)
Oral herpes	1/10 (10%)		0/10 (0%)		0/10 (0%)
Sinusitis	1/10 (10%)		0/10 (0%)		0/10 (0%)
Tinea cruris	1/10 (10%)		0/10 (0%)		0/10 (0%)
Tooth abscess	0/10 (0%)		1/10 (10%)		1/10 (10%)
Upper respiratory tract infection	2/10 (20%)		2/10 (20%)		1/10 (10%)
Urinary tract infection	1/10 (10%)		0/10 (0%)		0/10 (0%)
Vulvovaginal candidiasis	0/10 (0%)		1/10 (10%)		0/10 (0%)
Injury, poisoning and procedural complications
Ligament sprain	1/10 (10%)		0/10 (0%)		0/10 (0%)
Metabolism and nutrition disorders
Decreased appetite	1/10 (10%)		0/10 (0%)		0/10 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/10 (20%)		0/10 (0%)		0/10 (0%)
Back pain	0/10 (0%)		1/10 (10%)		0/10 (0%)
Muscle spasms	3/10 (30%)		0/10 (0%)		0/10 (0%)
Musculoskeletal chest pain	1/10 (10%)		0/10 (0%)		0/10 (0%)
Musculoskeletal pain	1/10 (10%)		0/10 (0%)		0/10 (0%)
Myalgia	2/10 (20%)		1/10 (10%)		1/10 (10%)
Pain in extremity	1/10 (10%)		0/10 (0%)		0/10 (0%)
Nervous system disorders
Disturbance in attention	0/10 (0%)		0/10 (0%)		1/10 (10%)
Dizziness	1/10 (10%)		0/10 (0%)		1/10 (10%)
Dysgeusia	1/10 (10%)		0/10 (0%)		0/10 (0%)
Headache	2/10 (20%)		4/10 (40%)		1/10 (10%)
Psychiatric disorders
Anxiety	0/10 (0%)		1/10 (10%)		1/10 (10%)
Insomnia	0/10 (0%)		2/10 (20%)		0/10 (0%)
Renal and urinary disorders
Micturition urgency	0/10 (0%)		0/10 (0%)		1/10 (10%)
Pollakiuria	0/10 (0%)		0/10 (0%)		1/10 (10%)
Reproductive system and breast disorders
Vaginal haemorrhage	0/10 (0%)		0/10 (0%)		1/10 (10%)
Respiratory, thoracic and mediastinal disorders
Cough	2/10 (20%)		2/10 (20%)		1/10 (10%)
Dyspnoea	0/10 (0%)		1/10 (10%)		0/10 (0%)
Nasal discomfort	1/10 (10%)		0/10 (0%)		0/10 (0%)
Sinus congestion	1/10 (10%)		0/10 (0%)		0/10 (0%)
Skin and subcutaneous tissue disorders
Acne	1/10 (10%)		0/10 (0%)		0/10 (0%)
Macule	1/10 (10%)		0/10 (0%)		0/10 (0%)
Pruritus	0/10 (0%)		1/10 (10%)		1/10 (10%)
Rash	0/10 (0%)		1/10 (10%)		0/10 (0%)
Rash papular	0/10 (0%)		2/10 (20%)		0/10 (0%)
Vascular disorders
Haematoma	1/10 (10%)		0/10 (0%)		0/10 (0%)
Hypertension	0/10 (0%)		1/10 (10%)		0/10 (0%)
Hypotension	0/10 (0%)		0/10 (0%)		1/10 (10%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Prior to submitting/presenting a manuscript or materials relating to a Study to a publisher, reviewer, or outside person, the Institution shall provide to Achillion a copy of all such manuscripts or materials, and Achillion shall have thirty (30) days to review and comment. The Institution shall, upon Achillion's request, further delay publication or presentation for a period of up to sixty (60) days to allow Achillion to protect its interests in any Achillion Inventions.